Adults 18 to 99, any sex, with Peripheral Artery Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Exercise Tolerance Assessed by Measuring Distance (m) Walked in 6-minutesPrimary· Maximal walking distances on a 6mwt were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values.
6-minutes walk test
Week 3
Group
Value
95% CI
Low Heat Thermotherapy
388.75
± 85.08
High Heat Thermotherapy
414.96
± 109.23
Week 6
Group
Value
95% CI
Low Heat Thermotherapy
404.29
± 83.05
High Heat Thermotherapy
419.73
± 113.83
Blood PressurePrimary· 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.
Participants have systolic, diastolic and mean blood pressure recording 14 times during baseline, week 3 and week 6 experimental sessions.
Systolic BP Week 3
Group
Value
95% CI
Low Heat Thermotherapy
146.29
± 17.08
High Heat Thermotherapy
148.97
± 12.51
Systolic BP Week 6
Group
Value
95% CI
Low Heat Thermotherapy
149.84
± 9.61
High Heat Thermotherapy
150.21
± 15.38
Diastolic BP Week 3
Group
Value
95% CI
Low Heat Thermotherapy
79.38
± 10.74
High Heat Thermotherapy
79.72
± 9.42
Diastolic BP Week 6
Group
Value
95% CI
Low Heat Thermotherapy
80.31
± 8.98
High Heat Thermotherapy
81.44
± 8.64
Mean Arterial Pressure Week 3
Group
Value
95% CI
Low Heat Thermotherapy
101.69
± 12.18
High Heat Thermotherapy
102.81
± 9.33
Mean Arterial Pressure Week 6
Group
Value
95% CI
Low Heat Thermotherapy
103.48
± 7.90
High Heat Thermotherapy
104.36
± 9.39
Circulating Levels of Endothelin-1 (pg/mL)Primary· Serum endothelin-1 levels were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values.
Blood draw
Endothelin-1 Week 3
Group
Value
95% CI
Low Heat Thermotherapy
2.44
± 0.66
High Heat Thermotherapy
2.11
± 0.37
Endothelin-1 Week 6
Group
Value
95% CI
Low Heat Thermotherapy
2.60
± 0.69
High Heat Thermotherapy
2.00
± 0.35
Circulating Total Nitrate Levels (mmol)Primary· Serum total nitrate levels were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values.
Blood Draw
Total Nitrate Levels Week 3
Group
Value
95% CI
Low Heat Thermotherapy
63.62
± 30.60
High Heat Thermotherapy
47.61
± 21.31
Total Nitrate Levels Week 6
Group
Value
95% CI
Low Heat Thermotherapy
58.31
± 29.30
High Heat Thermotherapy
42.95
± 19.57
Vascular Function Assessed by Leg MRI to Measure Peak Blood Flow in Popliteal Artery (ml/s)Secondary· 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.
Week 3
Group
Value
95% CI
Low Heat Thermotherapy
4.25
± 2.54
High Heat Thermotherapy
4.85
± 1.94
Week 6
Group
Value
95% CI
Low Heat Thermotherapy
4.49
± 2.51
High Heat Thermotherapy
5.49
± 2.43
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)Secondary· Ankle-brachial index measures were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values.
Ankle-brachial Index
Week 3
Group
Value
95% CI
Low Heat Thermotherapy
0.64
± 0.14
High Heat Thermotherapy
0.71
± 0.13
Week 6
Group
Value
95% CI
Low Heat Thermotherapy
0.64
± 0.12
High Heat Thermotherapy
0.71
± 0.11
Vascular Function Measuring Leg Cutaneous Vascular Conductance - Measured by Laser-doppler Flowmetry of the SkinSecondary· 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.
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.
Week 3
Group
Value
95% CI
Low Heat Thermotherapy
55.08
± 3.691
High Heat Thermotherapy
56.09
± 4.892
Week 6
Group
Value
95% CI
Low Heat Thermotherapy
54.29
± 4.077
High Heat Thermotherapy
52.66
± 3.806
Patient Reported Functional Health and Well-being Using 36-item Short Form Health SurveySecondary· SF-36 questionnaires were administered at weeks 3/6 and 6/6 of the study and compared to baseline values.
36-item Short Form Health Survey. All scales are scored 1-100, with 1 being the poorest rating and 100 being the most optimal.
Physical Functioning Week 3
Group
Value
95% CI
Low Heat Thermotherapy
48.08
± 27.27
High Heat Thermotherapy
45.05
± 16.59
Physical Functioning Week 6
Group
Value
95% CI
Low Heat Thermotherapy
42.67
± 29.43
High Heat Thermotherapy
49.26
± 20.20
Role Physical Week 3
Group
Value
95% CI
Low Heat Thermotherapy
50.00
± 33.46
High Heat Thermotherapy
50.00
± 24.55
Role Physical Week 6
Group
Value
95% CI
Low Heat Thermotherapy
50.42
± 31.65
High Heat Thermotherapy
56.25
± 28.84
Bodily Pain Week 3
Group
Value
95% CI
Low Heat Thermotherapy
45.85
± 21.25
High Heat Thermotherapy
49.29
± 20.60
Bodily Pain Week 6
Group
Value
95% CI
Low Heat Thermotherapy
50.33
± 22.40
High Heat Thermotherapy
51.87
± 18.28
General Health Week 3
Group
Value
95% CI
Low Heat Thermotherapy
54.92
± 13.82
High Heat Thermotherapy
61.47
± 20.20
General Health Week 6
Group
Value
95% CI
Low Heat Thermotherapy
55.33
± 18.48
High Heat Thermotherapy
59.40
± 21.67
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse event data was collected for each participant over the course of 6 weeks of treatment..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study proposes to evaluate the potential of leg thermotherapy as a non-pharmacological intervention that could improve the mobility and exercise tolerance of patients with intermittent claudication. Thermotherapy is a simple, easily applicable therapy that enhances exercise tolerance in patients with chronic heart failure by improving peripheral vascular endothelial function.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Indiana University
Last refreshed: 10 February 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02770547.