N/A
Completed N=34
Home-based Leg Heat Therapy
Source: ClinicalTrials.gov NCT03763331 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcomePrimary: Change in 6-min Walk Distance — -0.9; 21.3 meters
Summary
The objective of this study is to evaluate the benefits of participating for 8 weeks in a home-based daily treatment with heat therapy (HT) or a thermoneutral control intervention, as assessed by vascular function, walking tolerance and quality of life.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in 6-min Walk Distance |
-0.9; 21.3 | — |
| SECONDARY Change in Treadmill Peak Walking Time |
61.5; 109.5 | — |
| SECONDARY Change in Peak Calf Blood Flow |
-4.8; -2.8 | — |
| SECONDARY Change in Leg Cutaneous Vascular Conductance |
-2.6; -0.7 | — |
| SECONDARY Change in the Vascular Quality of Life Questionnaire-6 Score |
0.6; 0.5 | — |
| SECONDARY Change in the Short Form 36 Physical Functioning Score |
4.5; 4.5 | — |
Eligibility Criteria
Inclusion Criteria
- Men and women with a stable symptomatic PAD for ≥6 months
- Ankle brachial index 8.5 measured within 3 months prior to date of consent)
- Wheelchair bound
- Use of a walking aid (i.e. cane, crutches, walker, motorized chair)
- Critical limb ischemia (ischemic rest pain or ischemia-related non healing wounds or tissue loss
- Impaired thermal sensation in the legs
- Exercise-limiting comorbidity
- Chronic Heart Failure stages C and stage D (Stage C: structural heart disease is present and symptoms have occurred; Stage D: presence of advanced heart disease with continued heart failure symptoms requiring aggressive medical therapy)
- Morbid obesity BMI > 35 or unable to fit into water-circulating pants
- Open wounds or ulcers on the extremity
- Prior amputation
- Lower extremity revascularization, major orthopedic surgery, cardiovascular event, or coronary revascularization in the previous three months
- Planned revascularization or major surgery during the next six months
- Plans to change medical therapy during the duration of the study
- Active treatment for cancer
- Chronic kidney disease (eGFR <30 by MDRD or Mayo or Cockcroft-Gault formula).
- HIV positive, active HBV or HCV disease.
- Presence of any clinical condition that makes the patient not suitable to participate in the trial.
- Unable to walk on the treadmill
Data sourced from ClinicalTrials.gov (NCT03763331). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.