Trial Outcomes & Findings for Cooling Leg and Foot Ulcer Skin Post Healing to Prevent Ulcer Recurrence (NCT NCT02626156)
NCT ID: NCT02626156
Last Updated: 2021-06-30
Results Overview
Number of recurrent ulcers that develop during the 6 month study period for in participants for 4 groups of patients with previously healed venous leg ulcers receiving the cooling gel pack and cooling cotton pack and those with previously healed diabetic foot ulcers receiving the cooling gel pack or cooling cotton pack.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
140 participants
Primary outcome timeframe
Through study completion at 6 months from baseline
Results posted on
2021-06-30
Participant Flow
Date recruitment period was January 2017 through December 2019 at wound clinics in the South and North Carolina areas including Charleston SC, Spartanburg SC and Greenville NC via clinicians practicing in those clinics and flyers were distributed in and around community settings such as senior centers, prior to approval from MUSC IRB.
246 individuals approached, 211 prescreened eligible, 71 ineligible due to type of wound, could not make regular appointments for study visits, not interested in study, lost contact or developed infection or ulcer changed in size (healed or enlarged indicating deterioration prior to eligibility screening visit); 140 were enrolled - 58 in the DFU group (29 intervention and 29 control)and 82 in VLU group (42 intervention and 40 control)
Participant milestones
| Measure |
Cooling Gel Pack Diabetic Foot Ulcer
A cooling pack was applied to affected foot skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling gel pack: Individuals self monitored temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
Cooling Cotton Pack Diabetic Foot Ulcer
A cooling cotton pack was applied to affected foot skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed venous leg or diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
Cooling Gel Pack Venous Leg Ulcer
A cooling pack was applied to affected leg skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling gel pack: Individuals self monitored temperature of skin over a recently healed venous leg or diabetic foot ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
Cooling Cotton Pack Venous Leg Ulcer
A cooling cotton pack was applied to affected leg skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
|---|---|---|---|---|
|
Baseline (Visit 1 to Visit 2)
STARTED
|
29
|
29
|
42
|
40
|
|
Baseline (Visit 1 to Visit 2)
COMPLETED
|
23
|
22
|
37
|
35
|
|
Baseline (Visit 1 to Visit 2)
NOT COMPLETED
|
6
|
7
|
5
|
5
|
|
Study Visit 3
STARTED
|
23
|
22
|
37
|
35
|
|
Study Visit 3
COMPLETED
|
15
|
17
|
33
|
33
|
|
Study Visit 3
NOT COMPLETED
|
8
|
5
|
4
|
2
|
|
Study Visit 4
STARTED
|
15
|
17
|
33
|
33
|
|
Study Visit 4
COMPLETED
|
12
|
15
|
24
|
28
|
|
Study Visit 4
NOT COMPLETED
|
3
|
2
|
9
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cooling Leg and Foot Ulcer Skin Post Healing to Prevent Ulcer Recurrence
Baseline characteristics by cohort
| Measure |
Cooling Gel Pack - Venous Leg Ulcer
n=42 Participants
A cooling pack was applied to affected leg skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling gel pack: Individuals self monitored temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
Cooling Cotton Pack - Venous Leg Ulcer
n=40 Participants
A cooling cotton pack was applied to affected leg skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
Cooling Gel Pack - Diabetic Foot Ulcer
n=29 Participants
A cooling pack was applied to affected foot skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling gel pack: Individuals self monitored temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
Cooling Cotton Pack - Diabetic Foot Ulcer
n=29 Participants
A cooling cotton pack was applied to affected foot skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
Total
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
64.2 years
STANDARD_DEVIATION 14.7 • n=5 Participants
|
64.8 years
STANDARD_DEVIATION 12.2 • n=7 Participants
|
57.8 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
61.3 years
STANDARD_DEVIATION 11.6 • n=4 Participants
|
62.4 years
STANDARD_DEVIATION 12.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
54 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
86 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
133 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
91 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=5 Participants
|
40 participants
n=7 Participants
|
29 participants
n=5 Participants
|
29 participants
n=4 Participants
|
140 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Through study completion at 6 months from baselinePopulation: A total of 140 participants were randomized to either the placebo control group (n=57; 34 VLU, 23 DFU) or the intervention (n=60; 35 VLU, 25 DFU), with a final completion of 117 individuals (84%)
Number of recurrent ulcers that develop during the 6 month study period for in participants for 4 groups of patients with previously healed venous leg ulcers receiving the cooling gel pack and cooling cotton pack and those with previously healed diabetic foot ulcers receiving the cooling gel pack or cooling cotton pack.
Outcome measures
| Measure |
Cooling Gel Pack - Venous Leg Ulcer
n=35 Participants
A cooling pack was applied to affected leg skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling gel pack: Individuals self monitored temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
Cooling Cotton Pack - Venous Leg Ulcer
n=34 Participants
A cooling cotton pack was applied to affected leg skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
Cooling Gel Pack - Diabetic Foot Ulcer
n=25 Participants
A cooling pack was applied to affected foot skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling gel pack: Individuals self monitored temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
Cotton Cooling Pack - Diabetic Foot Ulcer
n=23 Participants
A cooling cotton pack was applied to affected foot skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
|---|---|---|---|---|
|
Number of Participants With Ulcer Recurrence
|
6 participants
|
3 participants
|
11 participants
|
5 participants
|
PRIMARY outcome
Timeframe: Through study completion at 6 months from baselinePopulation: A total of 140 participants were randomized, with a final completion for this outcome of 83 individuals (59%)
Pain was measured with a visual analog scale and reported numerically (0 to 10 with 10 being the most severe pain) at baseline and at 6 months end of study
Outcome measures
| Measure |
Cooling Gel Pack - Venous Leg Ulcer
n=26 Participants
A cooling pack was applied to affected leg skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling gel pack: Individuals self monitored temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
Cooling Cotton Pack - Venous Leg Ulcer
n=29 Participants
A cooling cotton pack was applied to affected leg skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
Cooling Gel Pack - Diabetic Foot Ulcer
n=12 Participants
A cooling pack was applied to affected foot skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling gel pack: Individuals self monitored temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
Cotton Cooling Pack - Diabetic Foot Ulcer
n=16 Participants
A cooling cotton pack was applied to affected foot skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
|---|---|---|---|---|
|
Change in Pain (Worst Pain, Least Pain, Pain Now)
Worst pain
|
0.85 score on a scale
Interval -0.1 to 1.6
|
0.4 score on a scale
Interval -0.6 to 1.3
|
0 score on a scale
Interval -1.6 to 1.6
|
-1.0 score on a scale
Interval -2.3 to 0.3
|
|
Change in Pain (Worst Pain, Least Pain, Pain Now)
Least pain
|
0.3 score on a scale
Interval -0.2 to 0.8
|
0 score on a scale
Interval -0.6 to 0.6
|
-0.1 score on a scale
Interval -0.8 to 0.6
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Change in Pain (Worst Pain, Least Pain, Pain Now)
Pain now
|
0.4 score on a scale
Interval -0.06 to 0.9
|
0.14 score on a scale
Interval -0.3 to 0.5
|
0.1 score on a scale
Interval -0.1 to 0.3
|
-0.1 score on a scale
Interval -0.4 to 0.1
|
PRIMARY outcome
Timeframe: Through study completion at 6 months from baselinePopulation: A total of 140 participants were randomized, with a final completion for this outcome of 75 individuals (56%)
Differences in step counts reported via accelerometer data, from baseline to post treatment at 6 months end of intervention for the 4 groups.
Outcome measures
| Measure |
Cooling Gel Pack - Venous Leg Ulcer
n=23 Participants
A cooling pack was applied to affected leg skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling gel pack: Individuals self monitored temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
Cooling Cotton Pack - Venous Leg Ulcer
n=23 Participants
A cooling cotton pack was applied to affected leg skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
Cooling Gel Pack - Diabetic Foot Ulcer
n=15 Participants
A cooling pack was applied to affected foot skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling gel pack: Individuals self monitored temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
Cotton Cooling Pack - Diabetic Foot Ulcer
n=14 Participants
A cooling cotton pack was applied to affected foot skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
|---|---|---|---|---|
|
Differences in Step Counts
|
17295 Steps
Interval 9259.0 to 25332.0
|
14234 Steps
Interval 6874.0 to 21593.0
|
13232 Steps
Interval 2909.0 to 23555.0
|
15479 Steps
Interval 5614.0 to 25343.0
|
PRIMARY outcome
Timeframe: Through study completion at 6 months from baselinePopulation: Due to inadvertent scoring errors, there were data for 8 individuals.
The Venous Insufficiency Epidemiological and Economic Study-Quality of life/Symptoms (VEINES QOL/Sym) Questionnaire was used to evaluate quality of life. A sum score is provided as an overall quality of life score for both the QOL and Sym portions of the questionnaire. This instrument was used only for the VLU groups because it is a disease-specific measure. Of the 26 items in the questionnaire, 25 items are combined to create a summary score (VEINES-QOL). One item which asks about the time of day the leg problem is most intense, question 2, provides only descriptive information and is not scored. A subset (symptoms score) of ten of these items, questions 1a to 1i and 7, is used to create a symptom score (VEINES-Sym). For both the VEINES-QOL and VEINES-Sym scores, high values indicate better outcomes. VEINES-QOL scores can be compared only to other members of the same sample. Each set of VEINES-QOL scores will have a mean T-score = 50.
Outcome measures
| Measure |
Cooling Gel Pack - Venous Leg Ulcer
n=6 Participants
A cooling pack was applied to affected leg skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling gel pack: Individuals self monitored temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
Cooling Cotton Pack - Venous Leg Ulcer
n=2 Participants
A cooling cotton pack was applied to affected leg skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
Cooling Gel Pack - Diabetic Foot Ulcer
A cooling pack was applied to affected foot skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling gel pack: Individuals self monitored temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
Cotton Cooling Pack - Diabetic Foot Ulcer
A cooling cotton pack was applied to affected foot skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
|---|---|---|---|---|
|
Change in Mean Scores on Quality of Life Measured With the VEINES QOL/Sym Questionnaire
Quality of life
|
13.8 t-scores
Interval 4.0 to 23.5
|
-4.8 t-scores
Interval -121.6 to 111.9
|
—
|
—
|
|
Change in Mean Scores on Quality of Life Measured With the VEINES QOL/Sym Questionnaire
Symptoms
|
24.2 t-scores
Interval 13.8 to 34.5
|
-4.3 t-scores
Interval -7.4 to -1.1
|
—
|
—
|
PRIMARY outcome
Timeframe: Through study completion at 6 months from baselinePopulation: A total of 140 participants were randomized, with a final completion for this outcome of 83 individuals (59%)
The Brief Pain Inventory (BPI) scale is reported as an average score. BPI rapidly assesses the severity of pain and its impact on functioning for intensity and Pain Intensity and Pain Interference. Pain Intensity is measured in four categories: worst, least, on average, and currently, while Pain Interference is measured in 7 categories: mood, work, general activity, walking, relationships, enjoyment of life, and sleep. The patient rates each of these on a scale from 0-10, 10 being excruciating pain intensity and a complete interference in their life. Subscores are determined by averaging over the 4 intensity items for the severity subscore and over the 7 interference items for the interference subscore; possible total scores range from 0 to 10. Higher scores indicate worse intensity and severity.
Outcome measures
| Measure |
Cooling Gel Pack - Venous Leg Ulcer
n=26 Participants
A cooling pack was applied to affected leg skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling gel pack: Individuals self monitored temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
Cooling Cotton Pack - Venous Leg Ulcer
n=29 Participants
A cooling cotton pack was applied to affected leg skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
Cooling Gel Pack - Diabetic Foot Ulcer
n=12 Participants
A cooling pack was applied to affected foot skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling gel pack: Individuals self monitored temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
Cotton Cooling Pack - Diabetic Foot Ulcer
n=16 Participants
A cooling cotton pack was applied to affected foot skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
|---|---|---|---|---|
|
Changes in Severity and Intensity Pain Scores Measured With the Brief Pain Inventory
Interference
|
-0.4 score on a scale
Interval -0.8 to 0.08
|
-0.5 score on a scale
Interval -1.1 to 0.1
|
-0.1 score on a scale
Interval -0.2 to 0.1
|
0.1 score on a scale
Interval -0.2 to 0.3
|
|
Changes in Severity and Intensity Pain Scores Measured With the Brief Pain Inventory
Severity
|
-0.5 score on a scale
Interval -1.0 to 0.01
|
-0.2 score on a scale
Interval -0.8 to 0.4
|
0 score on a scale
Interval -0.5 to 0.5
|
0.4 score on a scale
Interval -0.1 to 0.9
|
PRIMARY outcome
Timeframe: Through study completion at 6 months from baselinePopulation: A total of 140 participants were randomized, with a final completion for this outcome of 82 individuals (59%)
Change in metabolic equivalent of task (METS) min per week for physical activity per The International Physical Activity Questionnaire reported for 4 groups from baseline to 6 months end of study. Scoring HIGH indicate physical activity levels equate to \~1hour of activity per day or more at least moderate intensity level or engage in vigorous intensity activity on at least 3 days achieving a minimum total physical activity of at least 1500 MET min a week or 7 or more days of any combination of walking, moderate intensity or vigorous intensity activities achieving a minimum total physical activity of at least 3000 MET min a week. MODERATE suggests engagement equivalent to 30 min of at least moderate intensity activity on most days; engage in 3 or more days of vigorous intensity activity and/or walking of at least 30 min per day or 5 or more days of moderate intensity activity and/or walking of at least 30 minutes per day. LOW level means that neither MODERATE or HIGH levels are met.
Outcome measures
| Measure |
Cooling Gel Pack - Venous Leg Ulcer
n=25 Participants
A cooling pack was applied to affected leg skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling gel pack: Individuals self monitored temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
Cooling Cotton Pack - Venous Leg Ulcer
n=29 Participants
A cooling cotton pack was applied to affected leg skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
Cooling Gel Pack - Diabetic Foot Ulcer
n=12 Participants
A cooling pack was applied to affected foot skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling gel pack: Individuals self monitored temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
Cotton Cooling Pack - Diabetic Foot Ulcer
n=16 Participants
A cooling cotton pack was applied to affected foot skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
|---|---|---|---|---|
|
Change in METS Minutes Engaging in Physical Activity Measured With The International Physical Activity Questionnaire
|
73 minutes
Interval -623.0 to 767.0
|
799 minutes
Interval -507.0 to 2104.0
|
1921 minutes
Interval 1151.0 to 4993.0
|
225 minutes
Interval -255.0 to 705.0
|
PRIMARY outcome
Timeframe: Through study completion at 6 months from baselinePopulation: A total of 140 participants were randomized, with a final completion for this outcome of 75 individuals (56%)
Mean time spent in minutes engaging in physical activities, reported via accelerometer data, from baseline to post treatment at 6 months end of intervention for the 4 groups.
Outcome measures
| Measure |
Cooling Gel Pack - Venous Leg Ulcer
n=23 Participants
A cooling pack was applied to affected leg skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling gel pack: Individuals self monitored temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
Cooling Cotton Pack - Venous Leg Ulcer
n=23 Participants
A cooling cotton pack was applied to affected leg skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
Cooling Gel Pack - Diabetic Foot Ulcer
n=15 Participants
A cooling pack was applied to affected foot skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling gel pack: Individuals self monitored temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
Cotton Cooling Pack - Diabetic Foot Ulcer
n=14 Participants
A cooling cotton pack was applied to affected foot skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
|---|---|---|---|---|
|
Time Spent in Minutes Engaging in Physical Activities
|
1420 Minutes
Interval -2448.0 to 5288.0
|
2523 Minutes
Interval -765.0 to 5811.0
|
135 Minutes
Interval 28.0 to 242.0
|
157 Minutes
Interval 55.0 to 260.0
|
SECONDARY outcome
Timeframe: Daily measures starting at baseline for temperature and every other day cooling application during the 6-month study period.Population: This outcome measured ALL participants in one group, rather than across arms, for adherence to temperature and use of cooling pack.
Using study data logs, appropriate use of the thermometer and cooling pack was measured by the number of participants who adhered to the protocol for taking the temperature of the skin over the healed venous leg or diabetic foot ulcer. Adherence was defined as: the number of participants who were at least 80% adherent to taking their temperatures with the infrared thermometer each morning and the number of participants who were at least 80% adherent to performing the intervention every other day = 3 times times per week during the 6-month study period.
Outcome measures
| Measure |
Cooling Gel Pack - Venous Leg Ulcer
n=121 Participants
A cooling pack was applied to affected leg skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling gel pack: Individuals self monitored temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
Cooling Cotton Pack - Venous Leg Ulcer
A cooling cotton pack was applied to affected leg skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
Cooling Gel Pack - Diabetic Foot Ulcer
A cooling pack was applied to affected foot skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling gel pack: Individuals self monitored temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
Cotton Cooling Pack - Diabetic Foot Ulcer
A cooling cotton pack was applied to affected foot skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
|---|---|---|---|---|
|
Participant Adherence to the Study Protocol
Cooling
|
82 Participants
|
—
|
—
|
—
|
|
Participant Adherence to the Study Protocol
Temperature
|
106 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Survey conducted at end of the 6-month study period.Population: A total of 140 participants were randomized, with a final completion for this outcome of 122 individuals (87%)
Patients satisfaction was measured by study personnel a during end of study phone survey with the following questions asked as follows (Yes/No): Were study instructions adequate, was thermometer easy to use, found cooling helpful, would cool skin area if it was proven that cooling prevented reulceration; (Easy/Not Easy): completing logs, performing the cooling treatment. Data are for (Yes/No) as number of participants who reported "yes" or if (Easy/Not Easy) the number of participants who reported "easy."
Outcome measures
| Measure |
Cooling Gel Pack - Venous Leg Ulcer
n=36 Participants
A cooling pack was applied to affected leg skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling gel pack: Individuals self monitored temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
Cooling Cotton Pack - Venous Leg Ulcer
n=34 Participants
A cooling cotton pack was applied to affected leg skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
Cooling Gel Pack - Diabetic Foot Ulcer
n=27 Participants
A cooling pack was applied to affected foot skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling gel pack: Individuals self monitored temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
Cotton Cooling Pack - Diabetic Foot Ulcer
n=25 Participants
A cooling cotton pack was applied to affected foot skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
|---|---|---|---|---|
|
Number of Participants Indicating 'Yes' or 'Easy' on Study Instructions, Thermometer Use, Completing Logs, Performing Treatment, Helpfulness
Using Thermometer Easy - Yes
|
36 count of participants
|
32 count of participants
|
27 count of participants
|
25 count of participants
|
|
Number of Participants Indicating 'Yes' or 'Easy' on Study Instructions, Thermometer Use, Completing Logs, Performing Treatment, Helpfulness
Completing Logs - Easy
|
36 count of participants
|
33 count of participants
|
27 count of participants
|
25 count of participants
|
|
Number of Participants Indicating 'Yes' or 'Easy' on Study Instructions, Thermometer Use, Completing Logs, Performing Treatment, Helpfulness
Study Instructions Adequate - Yes
|
36 count of participants
|
34 count of participants
|
26 count of participants
|
25 count of participants
|
|
Number of Participants Indicating 'Yes' or 'Easy' on Study Instructions, Thermometer Use, Completing Logs, Performing Treatment, Helpfulness
Performing Cooling -Treatment - Easy
|
35 count of participants
|
31 count of participants
|
26 count of participants
|
24 count of participants
|
|
Number of Participants Indicating 'Yes' or 'Easy' on Study Instructions, Thermometer Use, Completing Logs, Performing Treatment, Helpfulness
Cooling Helpful - Yes
|
31 count of participants
|
21 count of participants
|
21 count of participants
|
18 count of participants
|
|
Number of Participants Indicating 'Yes' or 'Easy' on Study Instructions, Thermometer Use, Completing Logs, Performing Treatment, Helpfulness
Would Cool if Found to Prevent Re-Ulceration - Yes
|
34 count of participants
|
33 count of participants
|
24 count of participants
|
25 count of participants
|
SECONDARY outcome
Timeframe: Baseline after participant enrollmentPopulation: Of 140 participants, 140 (100%) completed the questionnaire.
Participants were administered a 12-item (yes/no) questionnaire (test) during instruction at the start of the study, provided by the research personnel to determine comprehension of the protocol and to reinforce study procedures. Score of 12 or 100% was given for all items scoring correctly (1 point per item). Any items for which "no" was answered, remediation was conducted by study personnel at the time the questionnaire was conducted. Means scores are reported per VLU and DFU cooling pack intervention and VLU and DFU cotton cooling pack control.
Outcome measures
| Measure |
Cooling Gel Pack - Venous Leg Ulcer
n=42 Participants
A cooling pack was applied to affected leg skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling gel pack: Individuals self monitored temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
Cooling Cotton Pack - Venous Leg Ulcer
n=40 Participants
A cooling cotton pack was applied to affected leg skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
Cooling Gel Pack - Diabetic Foot Ulcer
n=29 Participants
A cooling pack was applied to affected foot skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling gel pack: Individuals self monitored temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
Cotton Cooling Pack - Diabetic Foot Ulcer
n=29 Participants
A cooling cotton pack was applied to affected foot skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
|---|---|---|---|---|
|
Knowledge Questionnaire of Study Instructions
|
11.7 score on a scale
Interval 11.0 to 12.0
|
11.9 score on a scale
Interval 11.0 to 12.0
|
11.8 score on a scale
Interval 11.0 to 12.0
|
11.9 score on a scale
Interval 11.0 to 12.0
|
Adverse Events
Cooling Gel Pack - Venous Leg Ulcer
Serious events: 4 serious events
Other events: 14 other events
Deaths: 1 deaths
Cooling Cotton Pack - Venous Leg Ulcer
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Cooling Gel Pack - Diabetic Foot Ulcer
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
Cooling Cotton Pack - Diabetic Foot Ulcer
Serious events: 4 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cooling Gel Pack - Venous Leg Ulcer
n=42 participants at risk
A cooling pack was applied to affected leg skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling gel pack: Individuals self monitored temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
Cooling Cotton Pack - Venous Leg Ulcer
n=40 participants at risk
A cooling cotton pack was applied to affected leg skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed leg ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
Cooling Gel Pack - Diabetic Foot Ulcer
n=29 participants at risk
A cooling pack was applied to affected foot skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling gel pack: Individuals self monitored temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
Cooling Cotton Pack - Diabetic Foot Ulcer
n=29 participants at risk
A cooling cotton pack was applied to affected foot skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed foot ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
|---|---|---|---|---|
|
Vascular disorders
Stroke
|
2.4%
1/42 • Number of events 1 • Data were collected for each participant for 6 months during study enrollment period.
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
|
0.00%
0/40 • Data were collected for each participant for 6 months during study enrollment period.
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
|
3.4%
1/29 • Number of events 1 • Data were collected for each participant for 6 months during study enrollment period.
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
|
0.00%
0/29 • Data were collected for each participant for 6 months during study enrollment period.
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
|
|
Cardiac disorders
Heart attack or failure
|
4.8%
2/42 • Number of events 2 • Data were collected for each participant for 6 months during study enrollment period.
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
|
0.00%
0/40 • Data were collected for each participant for 6 months during study enrollment period.
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
|
3.4%
1/29 • Number of events 1 • Data were collected for each participant for 6 months during study enrollment period.
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
|
0.00%
0/29 • Data were collected for each participant for 6 months during study enrollment period.
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
4.8%
2/42 • Number of events 2 • Data were collected for each participant for 6 months during study enrollment period.
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
|
0.00%
0/40 • Data were collected for each participant for 6 months during study enrollment period.
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
|
3.4%
1/29 • Number of events 1 • Data were collected for each participant for 6 months during study enrollment period.
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
|
0.00%
0/29 • Data were collected for each participant for 6 months during study enrollment period.
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
|
|
Infections and infestations
Infection
|
0.00%
0/42 • Data were collected for each participant for 6 months during study enrollment period.
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
|
2.5%
1/40 • Number of events 1 • Data were collected for each participant for 6 months during study enrollment period.
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
|
0.00%
0/29 • Data were collected for each participant for 6 months during study enrollment period.
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
|
3.4%
1/29 • Number of events 1 • Data were collected for each participant for 6 months during study enrollment period.
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
|
|
Ear and labyrinth disorders
Fainted
|
0.00%
0/42 • Data were collected for each participant for 6 months during study enrollment period.
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
|
0.00%
0/40 • Data were collected for each participant for 6 months during study enrollment period.
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
|
0.00%
0/29 • Data were collected for each participant for 6 months during study enrollment period.
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
|
3.4%
1/29 • Number of events 1 • Data were collected for each participant for 6 months during study enrollment period.
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
|
|
Vascular disorders
Amputation
|
0.00%
0/42 • Data were collected for each participant for 6 months during study enrollment period.
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
|
0.00%
0/40 • Data were collected for each participant for 6 months during study enrollment period.
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
|
0.00%
0/29 • Data were collected for each participant for 6 months during study enrollment period.
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
|
6.9%
2/29 • Number of events 2 • Data were collected for each participant for 6 months during study enrollment period.
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/42 • Data were collected for each participant for 6 months during study enrollment period.
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
|
2.5%
1/40 • Number of events 1 • Data were collected for each participant for 6 months during study enrollment period.
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
|
0.00%
0/29 • Data were collected for each participant for 6 months during study enrollment period.
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
|
0.00%
0/29 • Data were collected for each participant for 6 months during study enrollment period.
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
|
Other adverse events
| Measure |
Cooling Gel Pack - Venous Leg Ulcer
n=42 participants at risk
A cooling pack was applied to affected leg skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling gel pack: Individuals self monitored temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
Cooling Cotton Pack - Venous Leg Ulcer
n=40 participants at risk
A cooling cotton pack was applied to affected leg skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed leg ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
Cooling Gel Pack - Diabetic Foot Ulcer
n=29 participants at risk
A cooling pack was applied to affected foot skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling gel pack: Individuals self monitored temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
Cooling Cotton Pack - Diabetic Foot Ulcer
n=29 participants at risk
A cooling cotton pack was applied to affected foot skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline.
Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed foot ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature.
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
New ulcers
|
23.8%
10/42 • Number of events 10 • Data were collected for each participant for 6 months during study enrollment period.
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
|
12.5%
5/40 • Number of events 5 • Data were collected for each participant for 6 months during study enrollment period.
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
|
10.3%
3/29 • Number of events 3 • Data were collected for each participant for 6 months during study enrollment period.
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
|
13.8%
4/29 • Number of events 4 • Data were collected for each participant for 6 months during study enrollment period.
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
|
|
Skin and subcutaneous tissue disorders
Recurrent ulcers
|
14.3%
6/42 • Number of events 6 • Data were collected for each participant for 6 months during study enrollment period.
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
|
7.5%
3/40 • Number of events 3 • Data were collected for each participant for 6 months during study enrollment period.
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
|
37.9%
11/29 • Number of events 11 • Data were collected for each participant for 6 months during study enrollment period.
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
|
17.2%
5/29 • Number of events 5 • Data were collected for each participant for 6 months during study enrollment period.
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.4%
1/42 • Number of events 1 • Data were collected for each participant for 6 months during study enrollment period.
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
|
0.00%
0/40 • Data were collected for each participant for 6 months during study enrollment period.
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
|
0.00%
0/29 • Data were collected for each participant for 6 months during study enrollment period.
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
|
0.00%
0/29 • Data were collected for each participant for 6 months during study enrollment period.
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
|
|
Surgical and medical procedures
Surgery
|
0.00%
0/42 • Data were collected for each participant for 6 months during study enrollment period.
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
|
0.00%
0/40 • Data were collected for each participant for 6 months during study enrollment period.
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
|
10.3%
3/29 • Number of events 3 • Data were collected for each participant for 6 months during study enrollment period.
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
|
6.9%
2/29 • Number of events 2 • Data were collected for each participant for 6 months during study enrollment period.
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
|
|
Injury, poisoning and procedural complications
Injury
|
4.8%
2/42 • Number of events 2 • Data were collected for each participant for 6 months during study enrollment period.
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
|
2.5%
1/40 • Number of events 1 • Data were collected for each participant for 6 months during study enrollment period.
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
|
0.00%
0/29 • Data were collected for each participant for 6 months during study enrollment period.
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
|
6.9%
2/29 • Number of events 2 • Data were collected for each participant for 6 months during study enrollment period.
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
|
|
Infections and infestations
Infection
|
0.00%
0/42 • Data were collected for each participant for 6 months during study enrollment period.
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
|
0.00%
0/40 • Data were collected for each participant for 6 months during study enrollment period.
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
|
3.4%
1/29 • Number of events 1 • Data were collected for each participant for 6 months during study enrollment period.
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
|
0.00%
0/29 • Data were collected for each participant for 6 months during study enrollment period.
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place