Trial Outcomes & Findings for Treatment Response to Different Lymphoedema Compression Programs Using a Pneumatic Compression Device (NCT NCT02031627)
NCT ID: NCT02031627
Last Updated: 2021-07-20
Results Overview
Limb volume changes measured via perometry reported in change of ml of fluid. A negative value is associated with the clinically-desirable decrease in fluid.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
Results posted on
2021-07-20
Participant Flow
Participant milestones
| Measure |
Group A
12 consecutive days undergoing a 1-hour pneumatic compression treatment once per day (1 hour total daily)
|
Group B
5 consecutive days undergoing a 1-hour pneumatic compression treatment in the AM and 1 hour of treatment in the PM (2 hours total daily)
|
Group C
5 consecutive days undergoing 2 consecutive 1-hour pneumatic compression treatments in the AM and again in the PM (4 hours total daily)
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
7
|
|
Overall Study
COMPLETED
|
7
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment Response to Different Lymphoedema Compression Programs Using a Pneumatic Compression Device
Baseline characteristics by cohort
| Measure |
Group A
n=7 Participants
12 consecutive days undergoing a 1-hour pneumatic compression treatment once per day (1 hour total daily)
|
Group B
n=7 Participants
5 consecutive days undergoing a 1-hour pneumatic compression treatment in the AM and 1 hour of treatment in the PM (2 hours total daily)
|
Group C
n=7 Participants
5 consecutive days undergoing 2 consecutive 1-hour pneumatic compression treatments in the AM and again in the PM (4 hours total daily)
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
65.5 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
58.1 years
STANDARD_DEVIATION 11.1 • n=7 Participants
|
50.4 years
STANDARD_DEVIATION 18.3 • n=5 Participants
|
58.0 years
STANDARD_DEVIATION 13.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 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
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
|
Region of Enrollment
United Kingdom
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
7 participants
n=5 Participants
|
21 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)Limb volume changes measured via perometry reported in change of ml of fluid. A negative value is associated with the clinically-desirable decrease in fluid.
Outcome measures
| Measure |
Group A
n=7 Participants
12 consecutive days undergoing a 1-hour pneumatic compression treatment once per day (1 hour total daily)
|
Group B
n=7 Participants
5 consecutive days undergoing a 1-hour pneumatic compression treatment in the AM and 1 hour of treatment in the PM (2 hours total daily)
|
Group C
n=7 Participants
5 consecutive days undergoing 2 consecutive 1-hour pneumatic compression treatments in the AM and again in the PM (4 hours total daily)
|
|---|---|---|---|
|
Limb Volume (ml)
|
-197 ml
Standard Deviation 78
|
-60 ml
Standard Deviation 126
|
45 ml
Standard Deviation 381
|
PRIMARY outcome
Timeframe: Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)Limb volume changes measured via perometry reported in percent reduction. A negative value is associated with the clinically-desirable decrease in fluid.
Outcome measures
| Measure |
Group A
n=7 Participants
12 consecutive days undergoing a 1-hour pneumatic compression treatment once per day (1 hour total daily)
|
Group B
n=7 Participants
5 consecutive days undergoing a 1-hour pneumatic compression treatment in the AM and 1 hour of treatment in the PM (2 hours total daily)
|
Group C
n=7 Participants
5 consecutive days undergoing 2 consecutive 1-hour pneumatic compression treatments in the AM and again in the PM (4 hours total daily)
|
|---|---|---|---|
|
Limb Volume (% Change)
|
-2.6 % reduction
Standard Deviation 1.1
|
-0.7 % reduction
Standard Deviation 1.3
|
0.6 % reduction
Standard Deviation 4.5
|
PRIMARY outcome
Timeframe: Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)Change in skin tone (fibrosis) measured via tonometry. The tonometer is a mechanical device that gives an indication of the resistance of tissue to compression. It is used in lymphedema to give an estimate of the extent of pitting and fibrotic induration. Tonometry measures were collected at 5 anatomical locations. A negative value is associated with a clinically desirable decrease in tone.
Outcome measures
| Measure |
Group A
n=7 Participants
12 consecutive days undergoing a 1-hour pneumatic compression treatment once per day (1 hour total daily)
|
Group B
n=7 Participants
5 consecutive days undergoing a 1-hour pneumatic compression treatment in the AM and 1 hour of treatment in the PM (2 hours total daily)
|
Group C
n=7 Participants
5 consecutive days undergoing 2 consecutive 1-hour pneumatic compression treatments in the AM and again in the PM (4 hours total daily)
|
|---|---|---|---|
|
Change in Skin Tone
Dorsum of Central Foot
|
0.1 mm
Standard Deviation 0.7
|
0.5 mm
Standard Deviation 2.0
|
0.2 mm
Standard Deviation 1.1
|
|
Change in Skin Tone
Posterior to Medial Malleolus
|
-0.3 mm
Standard Deviation 1.6
|
-0.7 mm
Standard Deviation 3.6
|
-1.2 mm
Standard Deviation 3.3
|
|
Change in Skin Tone
7 cm From Bottom of Patella (along midline)
|
-0.6 mm
Standard Deviation 1.5
|
0.2 mm
Standard Deviation 2.0
|
0.8 mm
Standard Deviation 1.1
|
|
Change in Skin Tone
7 cm From Top of Patella (along midline)
|
-0.3 mm
Standard Deviation 1.2
|
-0.7 mm
Standard Deviation 3.6
|
-0.1 mm
Standard Deviation 1.1
|
|
Change in Skin Tone
7 cm Below Inguinal Crease (along midline)
|
-0.2 mm
Standard Deviation 5.0
|
-0.9 mm
Standard Deviation 3
|
-0.8 mm
Standard Deviation 2.1
|
|
Change in Skin Tone
Abdominal Wall (7 cm below umbilicus)
|
0.3 mm
Standard Deviation 0.5
|
-0.7 mm
Standard Deviation 2.4
|
0.3 mm
Standard Deviation 0.5
|
PRIMARY outcome
Timeframe: Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)Changes in patient-determined symptoms\* and change in affect the symptoms had on the subject. Measured via MYMOP (Measure Yourself Medical Outcome Profile) questionnaire. A low score indicates a good outcome. Scores range from 0 (as good as can be) to 6 (as bad as can be). \*Recorded symptoms were: Gr A, 1st symptom: none, abdominal pain and discomfort, swelling, physical, and worrying about granddaughters Gr B, 1st symptom: arthritis, hayfever, look of fat foot, right hand area of neck and shoulder, stairs, and swelling Gr C, 1st symptom: none, energy during dancing and gardening, frustration of not going out on own, swelling, mild longstanding depression, and MPT joint at base of small toe Gr A, 2nd symptom: fatigue, heaviness of leg, mental, and pain under knee Gr B, 2nd symptom: narrowed choice of footwear, shower in bath, and swollen left foot Gr C, 2nd symptom: being tired and aching all over, and shoes and clothing
Outcome measures
| Measure |
Group A
n=7 Participants
12 consecutive days undergoing a 1-hour pneumatic compression treatment once per day (1 hour total daily)
|
Group B
n=7 Participants
5 consecutive days undergoing a 1-hour pneumatic compression treatment in the AM and 1 hour of treatment in the PM (2 hours total daily)
|
Group C
n=7 Participants
5 consecutive days undergoing 2 consecutive 1-hour pneumatic compression treatments in the AM and again in the PM (4 hours total daily)
|
|---|---|---|---|
|
Patient Reported Outcomes - MYMOP
First Symptom (see Outcome Measure Description)
|
-1.8 score on a scale
Standard Deviation 1.9
|
-0.7 score on a scale
Standard Deviation 0.8
|
-0.3 score on a scale
Standard Deviation 1.3
|
|
Patient Reported Outcomes - MYMOP
Second Symptom (see Outcome Measure Description)
|
-1.3 score on a scale
Standard Deviation 1.2
|
0 score on a scale
Standard Deviation 0
|
-1.5 score on a scale
Standard Deviation 0.7
|
|
Patient Reported Outcomes - MYMOP
Activity
|
-1.4 score on a scale
Standard Deviation 0.9
|
-1.0 score on a scale
Standard Deviation 1.7
|
-0.5 score on a scale
Standard Deviation 0.7
|
|
Patient Reported Outcomes - MYMOP
Well-Being
|
-0.8 score on a scale
Standard Deviation 1.3
|
-0.3 score on a scale
Standard Deviation 1.8
|
0 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Change after initial treatment on day 1 and change baseline to end of day 5 for all groupsChanges in extra cellular fluid (ECF) on treated leg measured by bioimpedance. A negative number is indicative of a clinically desirable reduction in ECF.
Outcome measures
| Measure |
Group A
n=7 Participants
12 consecutive days undergoing a 1-hour pneumatic compression treatment once per day (1 hour total daily)
|
Group B
n=7 Participants
5 consecutive days undergoing a 1-hour pneumatic compression treatment in the AM and 1 hour of treatment in the PM (2 hours total daily)
|
Group C
n=7 Participants
5 consecutive days undergoing 2 consecutive 1-hour pneumatic compression treatments in the AM and again in the PM (4 hours total daily)
|
|---|---|---|---|
|
Cellular Fluid Changes (Ohms)
ECF change following initial treatment (ohms)
|
-5.8 ohms
Standard Deviation 17.4
|
-12.1 ohms
Standard Deviation 19.0
|
-3.8 ohms
Standard Deviation 15.1
|
|
Cellular Fluid Changes (Ohms)
ECF change from baseline to end of day 5 (ohms)
|
-12.3 ohms
Standard Deviation 22
|
-4.6 ohms
Standard Deviation 27.2
|
2.1 ohms
Standard Deviation 24.5
|
SECONDARY outcome
Timeframe: Change after initial treatment on day 1 and change baseline to end of day 5 for all groupsChanges in extra cellular fluid (ECF) on treated leg measured by bioimpedance. A negative number is indicative of a clinically desirable reduction in ECF.
Outcome measures
| Measure |
Group A
n=7 Participants
12 consecutive days undergoing a 1-hour pneumatic compression treatment once per day (1 hour total daily)
|
Group B
n=7 Participants
5 consecutive days undergoing a 1-hour pneumatic compression treatment in the AM and 1 hour of treatment in the PM (2 hours total daily)
|
Group C
n=7 Participants
5 consecutive days undergoing 2 consecutive 1-hour pneumatic compression treatments in the AM and again in the PM (4 hours total daily)
|
|---|---|---|---|
|
Cellular Fluid Changes (% Change)
ECF change following initial treatment (percent)
|
-2.5 percent fluid change
Standard Deviation 6.9
|
-4.5 percent fluid change
Standard Deviation 6.4
|
-1.2 percent fluid change
Standard Deviation 6.6
|
|
Cellular Fluid Changes (% Change)
ECF change from baseline to end of day 5 (percent)
|
-4.9 percent fluid change
Standard Deviation 8.0
|
-2.0 percent fluid change
Standard Deviation 10.5
|
1.1 percent fluid change
Standard Deviation 11.9
|
SECONDARY outcome
Timeframe: Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)Number of complications experienced. Incidence based on clinician assessment.
Outcome measures
| Measure |
Group A
n=7 Participants
12 consecutive days undergoing a 1-hour pneumatic compression treatment once per day (1 hour total daily)
|
Group B
n=7 Participants
5 consecutive days undergoing a 1-hour pneumatic compression treatment in the AM and 1 hour of treatment in the PM (2 hours total daily)
|
Group C
n=7 Participants
5 consecutive days undergoing 2 consecutive 1-hour pneumatic compression treatments in the AM and again in the PM (4 hours total daily)
|
|---|---|---|---|
|
Incidence of Complications
|
0 Complications
|
0 Complications
|
0 Complications
|
SECONDARY outcome
Timeframe: Day 1 compared to final treatment day (day 12 for Group A and day 5 for Groups B and C)Change in number of steps as accumulated each day monitored through use of a pedometer. A positive number indicates an increase in step count (activity) while a negative number indicates a decrease in step count.
Outcome measures
| Measure |
Group A
n=7 Participants
12 consecutive days undergoing a 1-hour pneumatic compression treatment once per day (1 hour total daily)
|
Group B
n=7 Participants
5 consecutive days undergoing a 1-hour pneumatic compression treatment in the AM and 1 hour of treatment in the PM (2 hours total daily)
|
Group C
n=7 Participants
5 consecutive days undergoing 2 consecutive 1-hour pneumatic compression treatments in the AM and again in the PM (4 hours total daily)
|
|---|---|---|---|
|
Activity Level
|
28 steps
Standard Deviation 281
|
-1284 steps
Standard Deviation 2144
|
1240 steps
Standard Deviation 1916
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)Change in skin thickness measured by ultrasound. Ultrasound measures were collected at 5 anatomical locations. A negative value is associated with a clinically desirable reduction in skin thickness (a surrogate measure of oedema).
Outcome measures
| Measure |
Group A
n=7 Participants
12 consecutive days undergoing a 1-hour pneumatic compression treatment once per day (1 hour total daily)
|
Group B
n=7 Participants
5 consecutive days undergoing a 1-hour pneumatic compression treatment in the AM and 1 hour of treatment in the PM (2 hours total daily)
|
Group C
n=7 Participants
5 consecutive days undergoing 2 consecutive 1-hour pneumatic compression treatments in the AM and again in the PM (4 hours total daily)
|
|---|---|---|---|
|
Change in Skin Thickness
Dorsum of Central Foot
|
-0.09 cm
Standard Deviation 0.13
|
0.02 cm
Standard Deviation 0.11
|
-0.02 cm
Standard Deviation 0.04
|
|
Change in Skin Thickness
Posterior to Medial Malleolus
|
0.12 cm
Standard Deviation 0.13
|
-0.06 cm
Standard Deviation 0.16
|
0.04 cm
Standard Deviation 0.12
|
|
Change in Skin Thickness
7 cm From Bottom of Patella (along midline)
|
-0.02 cm
Standard Deviation 0.08
|
0.00 cm
Standard Deviation 0.07
|
-0.03 cm
Standard Deviation 0.02
|
|
Change in Skin Thickness
7 cm From Top of Patella (along midline)
|
-0.01 cm
Standard Deviation 0.02
|
-0.01 cm
Standard Deviation 0.04
|
0.00 cm
Standard Deviation 0.05
|
|
Change in Skin Thickness
7 cm Below Inguinal Crease (along midline)
|
-0.01 cm
Standard Deviation 0.05
|
-0.01 cm
Standard Deviation 0.05
|
0.00 cm
Standard Deviation 0.03
|
|
Change in Skin Thickness
Abdominal Wall (7 cm below umbilicus)
|
-0.01 cm
Standard Deviation 0.04
|
0.00 cm
Standard Deviation 0.04
|
-0.02 cm
Standard Deviation 0.04
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)Change in local tissue water (LTW) within the skin measured by MoistureMeterD (MMD). MMD measures were collected at 5 anatomical locations using 2 probes: medium (M25) and large (L50). A negative value is associated with a clinically desirable decrease in LTW (a surrogate measure of oedema).
Outcome measures
| Measure |
Group A
n=7 Participants
12 consecutive days undergoing a 1-hour pneumatic compression treatment once per day (1 hour total daily)
|
Group B
n=7 Participants
5 consecutive days undergoing a 1-hour pneumatic compression treatment in the AM and 1 hour of treatment in the PM (2 hours total daily)
|
Group C
n=7 Participants
5 consecutive days undergoing 2 consecutive 1-hour pneumatic compression treatments in the AM and again in the PM (4 hours total daily)
|
|---|---|---|---|
|
Change in Local Tissue Water (LTW)
M25 Probe: Dorsum of Central Foot
|
1.9 cm
Standard Deviation 5.8
|
-1.1 cm
Standard Deviation 5.4
|
2.9 cm
Standard Deviation 10.8
|
|
Change in Local Tissue Water (LTW)
L50 Probe: Dorsum of Central Foot
|
6.4 cm
Standard Deviation 10.6
|
-6.3 cm
Standard Deviation 9.6
|
-0.9 cm
Standard Deviation 10.4
|
|
Change in Local Tissue Water (LTW)
M25 Probe: Posterior to Medial Malleolus
|
2.5 cm
Standard Deviation 6.0
|
3.2 cm
Standard Deviation 4.5
|
4.7 cm
Standard Deviation 6.0
|
|
Change in Local Tissue Water (LTW)
L50 Probe: Posterior to Medial Malleolus
|
-2.3 cm
Standard Deviation 5.4
|
3.4 cm
Standard Deviation 9.0
|
2.5 cm
Standard Deviation 6.3
|
|
Change in Local Tissue Water (LTW)
M25 Probe: 7 cm From Bottom of Patella (along midline)
|
2.3 cm
Standard Deviation 5.6
|
0.6 cm
Standard Deviation 5.5
|
2.0 cm
Standard Deviation 5.8
|
|
Change in Local Tissue Water (LTW)
L50 Probe: 7 cm From Bottom of Patella (along midline)
|
3.4 cm
Standard Deviation 6.9
|
-0.3 cm
Standard Deviation 3.5
|
0.1 cm
Standard Deviation 6.4
|
|
Change in Local Tissue Water (LTW)
M25 Probe: 7 cm From Top of Patella (along midline)
|
1.3 cm
Standard Deviation 1.6
|
2.4 cm
Standard Deviation 1.4
|
3.1 cm
Standard Deviation 4.4
|
|
Change in Local Tissue Water (LTW)
L50 Probe: 7 cm From Top of Patella (along midline)
|
-0.8 cm
Standard Deviation 1.6
|
-0.2 cm
Standard Deviation 1.8
|
3.2 cm
Standard Deviation 4.6
|
|
Change in Local Tissue Water (LTW)
M25 Probe: 7 cm Below Inguinal Crease (along midline)
|
1.3 cm
Standard Deviation 3.7
|
2.0 cm
Standard Deviation 2.1
|
0.9 cm
Standard Deviation 3.0
|
|
Change in Local Tissue Water (LTW)
L50 Probe: 7 cm Below Inguinal Crease (along midline)
|
-1.2 cm
Standard Deviation 1.5
|
1.3 cm
Standard Deviation 0.7
|
0.6 cm
Standard Deviation 1.9
|
|
Change in Local Tissue Water (LTW)
M25 Probe: Abdominal Wall (7 cm below umbilicus)
|
0.9 cm
Standard Deviation 3.6
|
0.9 cm
Standard Deviation 1.8
|
1.3 cm
Standard Deviation 5.3
|
|
Change in Local Tissue Water (LTW)
L50 Probe: Abdominal Wall (7 cm below umbilicus)
|
-0.1 cm
Standard Deviation 1.4
|
-1.1 cm
Standard Deviation 2.7
|
0.2 cm
Standard Deviation 1.6
|
POST_HOC outcome
Timeframe: Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)Self-reported changes in symptoms in 4 domains: function, appearance, symptoms, and emotion as well as general quality of life (QOL). Measured via LYMQOL (Lymphedema Quality of Life) questionnaire. A decrease in the the domain scores and increase in general QOL indicate a good outcome. Scores range from 1 to 4.
Outcome measures
| Measure |
Group A
n=7 Participants
12 consecutive days undergoing a 1-hour pneumatic compression treatment once per day (1 hour total daily)
|
Group B
n=7 Participants
5 consecutive days undergoing a 1-hour pneumatic compression treatment in the AM and 1 hour of treatment in the PM (2 hours total daily)
|
Group C
n=7 Participants
5 consecutive days undergoing 2 consecutive 1-hour pneumatic compression treatments in the AM and again in the PM (4 hours total daily)
|
|---|---|---|---|
|
Patient Reported Outcomes - LYMQOL
Function
|
-2.2 score on a scale
Standard Deviation 2.4
|
-0.8 score on a scale
Standard Deviation 2.9
|
0.1 score on a scale
Standard Deviation 3.4
|
|
Patient Reported Outcomes - LYMQOL
Appearance
|
-4.2 score on a scale
Standard Deviation 6.1
|
-0.6 score on a scale
Standard Deviation 4.0
|
-0.2 score on a scale
Standard Deviation 4.4
|
|
Patient Reported Outcomes - LYMQOL
Symptoms
|
-3.0 score on a scale
Standard Deviation 4.0
|
-1.6 score on a scale
Standard Deviation 2.9
|
-2.2 score on a scale
Standard Deviation 4.5
|
|
Patient Reported Outcomes - LYMQOL
Emotion
|
-1.4 score on a scale
Standard Deviation 3.1
|
-1.0 score on a scale
Standard Deviation 5.2
|
0.5 score on a scale
Standard Deviation 1.6
|
|
Patient Reported Outcomes - LYMQOL
Overall Quality of Life (QOL)
|
-0.7 score on a scale
Standard Deviation 0.5
|
-0.7 score on a scale
Standard Deviation 1.5
|
0.3 score on a scale
Standard Deviation 0.8
|
Adverse Events
Group A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group C
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place