N/A
N=32
Leg Thermotherapy for Intermittent Claudication
Peripheral Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT02770547 ↗Enrolled (actual)
32
Serious AEs
3.1%
Results posted
Feb 2020
Primary outcome: Primary: Exercise Tolerance Assessed by Measuring Distance (m) Walked in 6-minutes — 388.75; 414.96; 404.29; 419.73 meters
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Low Heat Thermotherapy (Device); High Heat Thermotherapy (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Exercise Tolerance Assessed by Measuring Distance (m) Walked in 6-minutes |
388.75; 414.96; 404.29; 419.73 | — |
| PRIMARY Blood Pressure |
146.29; 148.97; 149.84; 150.21; 79.38; 79.72 | — |
| PRIMARY Circulating Levels of Endothelin-1 (pg/mL) |
2.44; 2.11; 2.60; 2.00 | — |
| PRIMARY Circulating Total Nitrate Levels (mmol) |
63.62; 47.61; 58.31; 42.95 | — |
| SECONDARY Vascular Function Assessed by Leg MRI to Measure Peak Blood Flow in Popliteal Artery (ml/s) |
4.25; 4.85; 4.49; 5.49 | — |
| SECONDARY 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) |
0.64; 0.71; 0.64; 0.71 | — |
| SECONDARY Vascular Function Measuring Leg Cutaneous Vascular Conductance - Measured by Laser-doppler Flowmetry of the Skin |
55.08; 56.09; 54.29; 52.66 | — |
| SECONDARY Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey |
48.08; 45.05; 42.67; 49.26; 50.00; 50.00 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Men and women with a stable symptomatic claudication for ≥6 months
- Ankle brachial index 8.5 measured within 3 months prior to date of consent)
- Heart Failure
- Chronic Obstructive Pulmonary Disease
- Critical limb ischemia (ischemic rest pain or ischemia-related non healing wounds or tissue loss
- Prior amputation
- Exercise-limiting comorbidity (i.e., angina, chronic lung disease, or arthritis)
- Recent ( 35.
- Open wounds or ulcers on the extremity.
MRI Exclusions:
- Cardiac pacemaker
- Implanted cardiac defibrillator
- Aneurysm clips
- Carotid artery vascular clamp
- Neurostimulator
- Insulin or infusion pump
- Implanted drug infusion device
- Bone growth/fusion stimulator
- Cochlear, otologic, or ear implant
- History of claustrophobia or who are unable to lie flat or who do not fit inside the bore of the scanner
Data sourced from ClinicalTrials.gov (NCT02770547). 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.