Trial Outcomes & Findings for Leg Thermotherapy for Intermittent Claudication (NCT NCT02770547)
NCT ID: NCT02770547
Last Updated: 2020-02-10
Results Overview
6-minutes walk test
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
Maximal walking distances on a 6mwt were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values.
Results posted on
2020-02-10
Participant Flow
Participant milestones
| Measure |
Low Heat Thermotherapy
Low heat thermotherapy will be applied to subject's leg. Subject will wear a garment through which heated water is circulated which in turn supplies low heat to the subject's leg.
Low Heat Thermotherapy: Subject will wear a High Density LCG (Liquid Circulating Garment). Water will be heated and circulated through the garment, which in turn supplies low heat to the subject's leg.
|
High Heat Thermotherapy
High heat thermotherapy will be applied to subject's leg. Subject will wear a garment through which heated water is circulated which in turn supplies high heat to the subject's leg.
High Heat Thermotherapy: Subject will wear a High Density LCG (Liquid Circulating Garment). Water will be heated and circulated through the garment, which in turn supplies high heat to the subject's leg.
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|---|---|---|
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Overall Study
STARTED
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16
|
16
|
|
Overall Study
COMPLETED
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15
|
15
|
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Overall Study
NOT COMPLETED
|
1
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1
|
Reasons for withdrawal
| Measure |
Low Heat Thermotherapy
Low heat thermotherapy will be applied to subject's leg. Subject will wear a garment through which heated water is circulated which in turn supplies low heat to the subject's leg.
Low Heat Thermotherapy: Subject will wear a High Density LCG (Liquid Circulating Garment). Water will be heated and circulated through the garment, which in turn supplies low heat to the subject's leg.
|
High Heat Thermotherapy
High heat thermotherapy will be applied to subject's leg. Subject will wear a garment through which heated water is circulated which in turn supplies high heat to the subject's leg.
High Heat Thermotherapy: Subject will wear a High Density LCG (Liquid Circulating Garment). Water will be heated and circulated through the garment, which in turn supplies high heat to the subject's leg.
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|---|---|---|
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Overall Study
Patient non-compliant
|
1
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0
|
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Overall Study
Adverse Event
|
0
|
1
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Baseline Characteristics
Some MRI outputs were affected by technological problems and the data was subsequently removed from the final dataset. Addtionally, patients who could not undergo MRI due to non-compatible stenting or claustrophobia were also removed.
Baseline characteristics by cohort
| Measure |
Low Heat Thermotherapy
n=15 Participants
Low heat thermotherapy will be applied to subject's leg. Subject will wear a garment through which heated water is circulated which in turn supplies low heat to the subject's leg.
Low Heat Thermotherapy: Subject will wear a High Density LCG (Liquid Circulating Garment). Water will be heated and circulated through the garment, which in turn supplies low heat to the subject's leg.
|
High Heat Thermotherapy
n=15 Participants
High heat thermotherapy will be applied to subject's leg. Subject will wear a garment through which heated water is circulated which in turn supplies high heat to the subject's leg.
High Heat Thermotherapy: Subject will wear a High Density LCG (Liquid Circulating Garment). Water will be heated and circulated through the garment, which in turn supplies high heat to the subject's leg.
|
Total
n=30 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
69.00 years
STANDARD_DEVIATION 7.80 • n=15 Participants
|
68.73 years
STANDARD_DEVIATION 8.99 • n=15 Participants
|
68.87 years
STANDARD_DEVIATION 8.27 • n=30 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=15 Participants
|
1 Participants
n=15 Participants
|
4 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=15 Participants
|
14 Participants
n=15 Participants
|
26 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=15 Participants
|
4 Participants
n=15 Participants
|
6 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=15 Participants
|
11 Participants
n=15 Participants
|
24 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=30 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=15 Participants
|
15 participants
n=15 Participants
|
30 participants
n=30 Participants
|
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Height
|
173.45 cm
STANDARD_DEVIATION 7.09 • n=15 Participants
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175.20 cm
STANDARD_DEVIATION 6.71 • n=15 Participants
|
174.30 cm
STANDARD_DEVIATION 6.84 • n=30 Participants
|
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Weight
|
81.38 kg
STANDARD_DEVIATION 15.83 • n=15 Participants
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85.67 kg
STANDARD_DEVIATION 15.77 • n=15 Participants
|
83.45 kg
STANDARD_DEVIATION 15.67 • n=30 Participants
|
|
BMI
|
26.93 kg/m^2
STANDARD_DEVIATION 4.21 • n=15 Participants
|
27.81 kg/m^2
STANDARD_DEVIATION 4.11 • n=15 Participants
|
27.36 kg/m^2
STANDARD_DEVIATION 4.11 • n=30 Participants
|
|
Ankle-Brachial Index
|
0.64 Ratio
STANDARD_DEVIATION 0.11 • n=15 Participants
|
0.70 Ratio
STANDARD_DEVIATION 0.11 • n=15 Participants
|
0.67 Ratio
STANDARD_DEVIATION 0.11 • n=30 Participants
|
|
Number of Participants with Lower Limb Stents
|
6 Participants
n=15 Participants
|
7 Participants
n=15 Participants
|
13 Participants
n=30 Participants
|
|
Number of Participants with Type II Diabetes Mellitus
|
3 Participants
n=15 Participants
|
8 Participants
n=15 Participants
|
11 Participants
n=30 Participants
|
|
Smoker
|
7 Participants
n=15 Participants
|
6 Participants
n=15 Participants
|
13 Participants
n=30 Participants
|
|
6 minute walk test distance
|
386.38 meters
STANDARD_DEVIATION 85.08 • n=15 Participants
|
414.12 meters
STANDARD_DEVIATION 109.23 • n=15 Participants
|
400.25 meters
STANDARD_DEVIATION 97.23 • n=30 Participants
|
|
Maximum absolute peak blood flow
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3.87 ml/s
STANDARD_DEVIATION 1.89 • n=7 Participants • Some MRI outputs were affected by technological problems and the data was subsequently removed from the final dataset. Addtionally, patients who could not undergo MRI due to non-compatible stenting or claustrophobia were also removed.
|
5.73 ml/s
STANDARD_DEVIATION 3.30 • n=7 Participants • Some MRI outputs were affected by technological problems and the data was subsequently removed from the final dataset. Addtionally, patients who could not undergo MRI due to non-compatible stenting or claustrophobia were also removed.
|
4.80 ml/s
STANDARD_DEVIATION 2.78 • n=14 Participants • Some MRI outputs were affected by technological problems and the data was subsequently removed from the final dataset. Addtionally, patients who could not undergo MRI due to non-compatible stenting or claustrophobia were also removed.
|
|
Serum Endothelin-1
|
2.44 pg/ml
STANDARD_DEVIATION 0.51 • n=14 Participants • 1 participant could not under go blood draws and 1 participant's samples were deemed an outlier and subsequently removed.
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2.30 pg/ml
STANDARD_DEVIATION 0.49 • n=14 Participants • 1 participant could not under go blood draws and 1 participant's samples were deemed an outlier and subsequently removed.
|
2.37 pg/ml
STANDARD_DEVIATION 0.50 • n=28 Participants • 1 participant could not under go blood draws and 1 participant's samples were deemed an outlier and subsequently removed.
|
|
Serum Total Nitrate
|
64.32 uM
STANDARD_DEVIATION 66.33 • n=15 Participants • 1 participant could not under go blood draws.
|
42.19 uM
STANDARD_DEVIATION 25.74 • n=14 Participants • 1 participant could not under go blood draws.
|
53.64 uM
STANDARD_DEVIATION 51.32 • n=29 Participants • 1 participant could not under go blood draws.
|
|
Systolic Blood Pressure
|
149.13 mmHg
STANDARD_DEVIATION 12.45 • n=15 Participants
|
153.54 mmHg
STANDARD_DEVIATION 12.22 • n=15 Participants
|
151.34 mmHg
STANDARD_DEVIATION 12.33 • n=30 Participants
|
|
Diastolic Blood Pressure
|
80.82 mmHg
STANDARD_DEVIATION 10.37 • n=15 Participants
|
82.24 mmHg
STANDARD_DEVIATION 8.85 • n=15 Participants
|
81.53 mmHg
STANDARD_DEVIATION 9.50 • n=30 Participants
|
|
Mean Arterial Pressure
|
103.59 mmHg
STANDARD_DEVIATION 9.83 • n=15 Participants
|
106.01 mmHg
STANDARD_DEVIATION 8.82 • n=15 Participants
|
104.80 mmHg
STANDARD_DEVIATION 9.26 • n=30 Participants
|
|
Cutaneous Vascular Conductance
|
51.91 Percentage of maximum conductance
STANDARD_DEVIATION 4.23 • n=15 Participants
|
56.33 Percentage of maximum conductance
STANDARD_DEVIATION 2.78 • n=15 Participants
|
54.12 Percentage of maximum conductance
STANDARD_DEVIATION 2.52 • n=30 Participants
|
|
SF-36
Phyiscal Functioning
|
45.00 units on a scale
STANDARD_DEVIATION 26.02 • n=15 Participants
|
42.14 units on a scale
STANDARD_DEVIATION 16.14 • n=15 Participants
|
43.57 units on a scale
STANDARD_DEVIATION 21.29 • n=30 Participants
|
|
SF-36
Role Physical
|
45.09 units on a scale
STANDARD_DEVIATION 30.54 • n=15 Participants
|
41.96 units on a scale
STANDARD_DEVIATION 21.01 • n=15 Participants
|
43.53 units on a scale
STANDARD_DEVIATION 25.77 • n=30 Participants
|
|
SF-36
Bodily Pain
|
49.57 units on a scale
STANDARD_DEVIATION 29.87 • n=15 Participants
|
44.93 units on a scale
STANDARD_DEVIATION 14.98 • n=15 Participants
|
47.17 units on a scale
STANDARD_DEVIATION 23.07 • n=30 Participants
|
|
SF-36
General Health
|
54.81 units on a scale
STANDARD_DEVIATION 20.78 • n=15 Participants
|
58.93 units on a scale
STANDARD_DEVIATION 17.85 • n=15 Participants
|
56.94 units on a scale
STANDARD_DEVIATION 19.08 • n=30 Participants
|
|
SF-36
Vitality
|
45.54 units on a scale
STANDARD_DEVIATION 26.34 • n=15 Participants
|
50.83 units on a scale
STANDARD_DEVIATION 19.75 • n=15 Participants
|
48.28 units on a scale
STANDARD_DEVIATION 22.90 • n=30 Participants
|
|
SF-36
Social Functioning
|
67.86 units on a scale
STANDARD_DEVIATION 26.73 • n=15 Participants
|
65.00 units on a scale
STANDARD_DEVIATION 26.81 • n=15 Participants
|
66.38 units on a scale
STANDARD_DEVIATION 26.33 • n=30 Participants
|
|
SF-36
Role Emotional
|
70.24 units on a scale
STANDARD_DEVIATION 31.98 • n=15 Participants
|
60.71 units on a scale
STANDARD_DEVIATION 33.40 • n=15 Participants
|
65.48 units on a scale
STANDARD_DEVIATION 32.45 • n=30 Participants
|
|
SF-36
Mental Health
|
77.86 units on a scale
STANDARD_DEVIATION 17.40 • n=15 Participants
|
72.00 units on a scale
STANDARD_DEVIATION 19.16 • n=15 Participants
|
74.83 units on a scale
STANDARD_DEVIATION 18.25 • n=30 Participants
|
PRIMARY outcome
Timeframe: Maximal walking distances on a 6mwt were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values.Population: Included all participants that completed the study.
6-minutes walk test
Outcome measures
| Measure |
Low Heat Thermotherapy
n=15 Participants
Low heat thermotherapy will be applied to subject's leg. Subject will wear a garment through which heated water is circulated which in turn supplies low heat to the subject's leg.
Low Heat Thermotherapy: Subject will wear a High Density LCG (Liquid Circulating Garment). Water will be heated and circulated through the garment, which in turn supplies low heat to the subject's leg.
|
High Heat Thermotherapy
n=15 Participants
High heat thermotherapy will be applied to subject's leg. Subject will wear a garment through which heated water is circulated which in turn supplies high heat to the subject's leg.
High Heat Thermotherapy: Subject will wear a High Density LCG (Liquid Circulating Garment). Water will be heated and circulated through the garment, which in turn supplies high heat to the subject's leg.
|
|---|---|---|
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Exercise Tolerance Assessed by Measuring Distance (m) Walked in 6-minutes
Week 3
|
388.75 meters
Standard Deviation 85.08
|
414.96 meters
Standard Deviation 109.23
|
|
Exercise Tolerance Assessed by Measuring Distance (m) Walked in 6-minutes
Week 6
|
404.29 meters
Standard Deviation 83.05
|
419.73 meters
Standard Deviation 113.83
|
PRIMARY outcome
Timeframe: Average blood pressure taken every 5 minutes for 70 minutes was obtained at weeks 3/6 and 6/6 of the study and compared to baseline values.Population: Includes all participants that completed the study.
Participants have systolic, diastolic and mean blood pressure recording 14 times during baseline, week 3 and week 6 experimental sessions.
Outcome measures
| Measure |
Low Heat Thermotherapy
n=15 Participants
Low heat thermotherapy will be applied to subject's leg. Subject will wear a garment through which heated water is circulated which in turn supplies low heat to the subject's leg.
Low Heat Thermotherapy: Subject will wear a High Density LCG (Liquid Circulating Garment). Water will be heated and circulated through the garment, which in turn supplies low heat to the subject's leg.
|
High Heat Thermotherapy
n=15 Participants
High heat thermotherapy will be applied to subject's leg. Subject will wear a garment through which heated water is circulated which in turn supplies high heat to the subject's leg.
High Heat Thermotherapy: Subject will wear a High Density LCG (Liquid Circulating Garment). Water will be heated and circulated through the garment, which in turn supplies high heat to the subject's leg.
|
|---|---|---|
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Blood Pressure
Systolic BP Week 3
|
146.29 mmHg
Standard Deviation 17.08
|
148.97 mmHg
Standard Deviation 12.51
|
|
Blood Pressure
Systolic BP Week 6
|
149.84 mmHg
Standard Deviation 9.61
|
150.21 mmHg
Standard Deviation 15.38
|
|
Blood Pressure
Diastolic BP Week 3
|
79.38 mmHg
Standard Deviation 10.74
|
79.72 mmHg
Standard Deviation 9.42
|
|
Blood Pressure
Diastolic BP Week 6
|
80.31 mmHg
Standard Deviation 8.98
|
81.44 mmHg
Standard Deviation 8.64
|
|
Blood Pressure
Mean Arterial Pressure Week 3
|
101.69 mmHg
Standard Deviation 12.18
|
102.81 mmHg
Standard Deviation 9.33
|
|
Blood Pressure
Mean Arterial Pressure Week 6
|
103.48 mmHg
Standard Deviation 7.90
|
104.36 mmHg
Standard Deviation 9.39
|
PRIMARY outcome
Timeframe: Serum endothelin-1 levels were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values.Population: One participant was excluded as an outlier from the low heat group. One participant in the high heat group did not have blood draws
Blood draw
Outcome measures
| Measure |
Low Heat Thermotherapy
n=14 Participants
Low heat thermotherapy will be applied to subject's leg. Subject will wear a garment through which heated water is circulated which in turn supplies low heat to the subject's leg.
Low Heat Thermotherapy: Subject will wear a High Density LCG (Liquid Circulating Garment). Water will be heated and circulated through the garment, which in turn supplies low heat to the subject's leg.
|
High Heat Thermotherapy
n=14 Participants
High heat thermotherapy will be applied to subject's leg. Subject will wear a garment through which heated water is circulated which in turn supplies high heat to the subject's leg.
High Heat Thermotherapy: Subject will wear a High Density LCG (Liquid Circulating Garment). Water will be heated and circulated through the garment, which in turn supplies high heat to the subject's leg.
|
|---|---|---|
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Circulating Levels of Endothelin-1 (pg/mL)
Endothelin-1 Week 3
|
2.44 pg/mL
Standard Deviation 0.66
|
2.11 pg/mL
Standard Deviation 0.37
|
|
Circulating Levels of Endothelin-1 (pg/mL)
Endothelin-1 Week 6
|
2.60 pg/mL
Standard Deviation 0.69
|
2.00 pg/mL
Standard Deviation 0.35
|
PRIMARY outcome
Timeframe: Serum total nitrate levels were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values.Population: One participant was excluded as an outlier from the low heat group. One participant in the high heat group did not have blood draws
Blood Draw
Outcome measures
| Measure |
Low Heat Thermotherapy
n=14 Participants
Low heat thermotherapy will be applied to subject's leg. Subject will wear a garment through which heated water is circulated which in turn supplies low heat to the subject's leg.
Low Heat Thermotherapy: Subject will wear a High Density LCG (Liquid Circulating Garment). Water will be heated and circulated through the garment, which in turn supplies low heat to the subject's leg.
|
High Heat Thermotherapy
n=14 Participants
High heat thermotherapy will be applied to subject's leg. Subject will wear a garment through which heated water is circulated which in turn supplies high heat to the subject's leg.
High Heat Thermotherapy: Subject will wear a High Density LCG (Liquid Circulating Garment). Water will be heated and circulated through the garment, which in turn supplies high heat to the subject's leg.
|
|---|---|---|
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Circulating Total Nitrate Levels (mmol)
Total Nitrate Levels Week 3
|
63.62 mmol
Standard Deviation 30.60
|
47.61 mmol
Standard Deviation 21.31
|
|
Circulating Total Nitrate Levels (mmol)
Total Nitrate Levels Week 6
|
58.31 mmol
Standard Deviation 29.30
|
42.95 mmol
Standard Deviation 19.57
|
SECONDARY outcome
Timeframe: Peak flows after post-occlusive reactive hyperemia were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values.Phase contrast magnetic resonance imaging was performed on the leg that the patient indicated to have the most severe claudication. An inflation cuff was placed around the thigh and inflated to 75 mmHg above resting brachial systolic pressure for 5 minutes. After 5 minutes of inflation, the cuff was release and an additional 10 minutes of imaging took place.
Outcome measures
| Measure |
Low Heat Thermotherapy
n=7 Participants
Low heat thermotherapy will be applied to subject's leg. Subject will wear a garment through which heated water is circulated which in turn supplies low heat to the subject's leg.
Low Heat Thermotherapy: Subject will wear a High Density LCG (Liquid Circulating Garment). Water will be heated and circulated through the garment, which in turn supplies low heat to the subject's leg.
|
High Heat Thermotherapy
n=5 Participants
High heat thermotherapy will be applied to subject's leg. Subject will wear a garment through which heated water is circulated which in turn supplies high heat to the subject's leg.
High Heat Thermotherapy: Subject will wear a High Density LCG (Liquid Circulating Garment). Water will be heated and circulated through the garment, which in turn supplies high heat to the subject's leg.
|
|---|---|---|
|
Vascular Function Assessed by Leg MRI to Measure Peak Blood Flow in Popliteal Artery (ml/s)
Week 3
|
4.25 ml/s
Standard Deviation 2.54
|
4.85 ml/s
Standard Deviation 1.94
|
|
Vascular Function Assessed by Leg MRI to Measure Peak Blood Flow in Popliteal Artery (ml/s)
Week 6
|
4.49 ml/s
Standard Deviation 2.51
|
5.49 ml/s
Standard Deviation 2.43
|
SECONDARY outcome
Timeframe: Ankle-brachial index measures were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values.Population: Includes all participants that completed the study.
Ankle-brachial Index
Outcome measures
| Measure |
Low Heat Thermotherapy
n=15 Participants
Low heat thermotherapy will be applied to subject's leg. Subject will wear a garment through which heated water is circulated which in turn supplies low heat to the subject's leg.
Low Heat Thermotherapy: Subject will wear a High Density LCG (Liquid Circulating Garment). Water will be heated and circulated through the garment, which in turn supplies low heat to the subject's leg.
|
High Heat Thermotherapy
n=15 Participants
High heat thermotherapy will be applied to subject's leg. Subject will wear a garment through which heated water is circulated which in turn supplies high heat to the subject's leg.
High Heat Thermotherapy: Subject will wear a High Density LCG (Liquid Circulating Garment). Water will be heated and circulated through the garment, which in turn supplies high heat to the subject's leg.
|
|---|---|---|
|
Vascular Function Measured by Ankle-brachial Index - Calculated by Dividing Higher of Posterior Tibial or Dorsalis Pedis Blood Pressure (mmHg) by Higher of Right or Left Arm Systolic Blood Pressure (mmHg)
Week 3
|
0.64 ratio
Standard Deviation 0.14
|
0.71 ratio
Standard Deviation 0.13
|
|
Vascular Function Measured by Ankle-brachial Index - Calculated by Dividing Higher of Posterior Tibial or Dorsalis Pedis Blood Pressure (mmHg) by Higher of Right or Left Arm Systolic Blood Pressure (mmHg)
Week 6
|
0.64 ratio
Standard Deviation 0.12
|
0.71 ratio
Standard Deviation 0.11
|
SECONDARY outcome
Timeframe: Maximal cutaneous vascular conductance values after 40 minutes of localized heating were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values.Population: Includes all participants that completed the study.
Laser-Doppler flowmetry of skin included placement of two heating probes on the anterior portion of the lower leg. The participant sat in a semi-recumbent position for 70 minutes while the temperature of the probe progressed from 33C to 39C at minute 10 and then to 43C at minute 50. Cutaneous vascular conductance was calculated at the average red blood cell flux during the final 2 minutes of the 39C heating portion divided by the mean arterial pressure taken at that time.
Outcome measures
| Measure |
Low Heat Thermotherapy
n=15 Participants
Low heat thermotherapy will be applied to subject's leg. Subject will wear a garment through which heated water is circulated which in turn supplies low heat to the subject's leg.
Low Heat Thermotherapy: Subject will wear a High Density LCG (Liquid Circulating Garment). Water will be heated and circulated through the garment, which in turn supplies low heat to the subject's leg.
|
High Heat Thermotherapy
n=15 Participants
High heat thermotherapy will be applied to subject's leg. Subject will wear a garment through which heated water is circulated which in turn supplies high heat to the subject's leg.
High Heat Thermotherapy: Subject will wear a High Density LCG (Liquid Circulating Garment). Water will be heated and circulated through the garment, which in turn supplies high heat to the subject's leg.
|
|---|---|---|
|
Vascular Function Measuring Leg Cutaneous Vascular Conductance - Measured by Laser-doppler Flowmetry of the Skin
Week 3
|
55.08 percentage of maximum conductance
Standard Deviation 3.691
|
56.09 percentage of maximum conductance
Standard Deviation 4.892
|
|
Vascular Function Measuring Leg Cutaneous Vascular Conductance - Measured by Laser-doppler Flowmetry of the Skin
Week 6
|
54.29 percentage of maximum conductance
Standard Deviation 4.077
|
52.66 percentage of maximum conductance
Standard Deviation 3.806
|
SECONDARY outcome
Timeframe: SF-36 questionnaires were administered at weeks 3/6 and 6/6 of the study and compared to baseline values.Population: Includes all participants that completed the study.
36-item Short Form Health Survey. All scales are scored 1-100, with 1 being the poorest rating and 100 being the most optimal.
Outcome measures
| Measure |
Low Heat Thermotherapy
n=15 Participants
Low heat thermotherapy will be applied to subject's leg. Subject will wear a garment through which heated water is circulated which in turn supplies low heat to the subject's leg.
Low Heat Thermotherapy: Subject will wear a High Density LCG (Liquid Circulating Garment). Water will be heated and circulated through the garment, which in turn supplies low heat to the subject's leg.
|
High Heat Thermotherapy
n=15 Participants
High heat thermotherapy will be applied to subject's leg. Subject will wear a garment through which heated water is circulated which in turn supplies high heat to the subject's leg.
High Heat Thermotherapy: Subject will wear a High Density LCG (Liquid Circulating Garment). Water will be heated and circulated through the garment, which in turn supplies high heat to the subject's leg.
|
|---|---|---|
|
Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey
Physical Functioning Week 3
|
48.08 units on a scale
Standard Deviation 27.27
|
45.05 units on a scale
Standard Deviation 16.59
|
|
Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey
Physical Functioning Week 6
|
42.67 units on a scale
Standard Deviation 29.43
|
49.26 units on a scale
Standard Deviation 20.20
|
|
Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey
Role Physical Week 3
|
50.00 units on a scale
Standard Deviation 33.46
|
50.00 units on a scale
Standard Deviation 24.55
|
|
Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey
Role Physical Week 6
|
50.42 units on a scale
Standard Deviation 31.65
|
56.25 units on a scale
Standard Deviation 28.84
|
|
Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey
Bodily Pain Week 3
|
45.85 units on a scale
Standard Deviation 21.25
|
49.29 units on a scale
Standard Deviation 20.60
|
|
Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey
Bodily Pain Week 6
|
50.33 units on a scale
Standard Deviation 22.40
|
51.87 units on a scale
Standard Deviation 18.28
|
|
Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey
General Health Week 3
|
54.92 units on a scale
Standard Deviation 13.82
|
61.47 units on a scale
Standard Deviation 20.20
|
|
Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey
General Health Week 6
|
55.33 units on a scale
Standard Deviation 18.48
|
59.40 units on a scale
Standard Deviation 21.67
|
|
Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey
Vitality Week 3
|
50.00 units on a scale
Standard Deviation 21.95
|
52.08 units on a scale
Standard Deviation 20.41
|
|
Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey
Vitality Week 6
|
55.00 units on a scale
Standard Deviation 21.80
|
55.00 units on a scale
Standard Deviation 22.19
|
|
Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey
Social Functioning Week 3
|
79.81 units on a scale
Standard Deviation 30.85
|
75.00 units on a scale
Standard Deviation 24.02
|
|
Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey
Social Functioning Week 6
|
75.83 units on a scale
Standard Deviation 27.33
|
72.50 units on a scale
Standard Deviation 24.64
|
|
Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey
Role Emotinoal Week 3
|
80.77 units on a scale
Standard Deviation 27.51
|
65.00 units on a scale
Standard Deviation 30.57
|
|
Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey
Role Emotional Week 6
|
71.67 units on a scale
Standard Deviation 29.18
|
64.44 units on a scale
Standard Deviation 30.12
|
|
Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey
Mental Health Week 3
|
81.92 units on a scale
Standard Deviation 16.90
|
72.33 units on a scale
Standard Deviation 16.99
|
|
Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey
Mental Health Week 6
|
79.67 units on a scale
Standard Deviation 14.33
|
71.33 units on a scale
Standard Deviation 22.71
|
Adverse Events
Low Heat Thermotherapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High Heat Thermotherapy
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Low Heat Thermotherapy
n=16 participants at risk
Low heat thermotherapy will be applied to subject's leg. Subject will wear a garment through which heated water is circulated which in turn supplies low heat to the subject's leg.
Low Heat Thermotherapy: Subject will wear a High Density LCG (Liquid Circulating Garment). Water will be heated and circulated through the garment, which in turn supplies low heat to the subject's leg.
|
High Heat Thermotherapy
n=16 participants at risk
High heat thermotherapy will be applied to subject's leg. Subject will wear a garment through which heated water is circulated which in turn supplies high heat to the subject's leg.
High Heat Thermotherapy: Subject will wear a High Density LCG (Liquid Circulating Garment). Water will be heated and circulated through the garment, which in turn supplies high heat to the subject's leg.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Surface level burn
|
0.00%
0/16 • Adverse event data was collected for each participant over the course of 6 weeks of treatment.
|
6.2%
1/16 • Number of events 1 • Adverse event data was collected for each participant over the course of 6 weeks of treatment.
|
Other adverse events
Adverse event data not reported
Additional Information
Bruno Roseguini, Assistant Professor
Purdue University
Phone: (765) 496-2612
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place