Leg Thermotherapy for Intermittent Claudication

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02770547
• Date of registration: 05/05/2016
• Prospective Registration: Yes
• Primary sponsor: Indiana University
• Public title: Leg Thermotherapy for Intermittent Claudication
• Scientific title: Leg Thermotherapy for Intermittent Claudication
• Date of first enrolment: May 30, 2016
• Target sample size: 32
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02770547
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Bruno Tesini Roseguini, PhD
• Affiliation: Purdue University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Men and women with a stable symptomatic claudication for =6 months

- Ankle brachial index <0.9

Exclusion Criteria:

- Uncontrolled Diabetes (HbA1C > 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 (<3 months) infrainguinal revascularization (surgery or endovascular
revascularization) or revascularization planned during study period.

- Plans to change medical therapy during the duration of the study

- Active cancer

- Chronic kidney disease (eGFR <30 by Modification of Diet in Renal Disease or Mayo or
Cockcroft-Gault formula).

- HIV positive, active hepatitis B virus (HBV) or hepatitis C virus (HCV) disease.

- Presence of any clinical condition that in the opinion of the principal investigator
makes the patient not suitable to participate in the trial.

- Peripheral neuropathy, numbness, or paresthesia in the legs.

- Morbid obesity BMI > 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



Age minimum: 18 Years
Age maximum: 99 Years
Gender: All

Health Condition(s) or Problem(s) studied

Peripheral Artery Disease

Intervention(s)

Device: Low Heat Thermotherapy

Device: High Heat Thermotherapy

Primary Outcome(s)

Blood Pressure [Time Frame: 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.]

Circulating Levels of Endothelin-1 (pg/mL) [Time Frame: Serum endothelin-1 levels were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values.]

Circulating Total Nitrate Levels (mmol) [Time Frame: Serum total nitrate levels were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values.]

Exercise Tolerance Assessed by Measuring Distance (m) Walked in 6-minutes [Time Frame: Maximal walking distances on a 6mwt were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values.]

Secondary Outcome(s)

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) [Time Frame: Ankle-brachial index measures were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values.]

Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey [Time Frame: SF-36 questionnaires were administered at weeks 3/6 and 6/6 of the study and compared to baseline values.]

Vascular Function Assessed by Leg MRI to Measure Peak Blood Flow in Popliteal Artery (ml/s) [Time Frame: Peak flows after post-occlusive reactive hyperemia were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values.]

Vascular Function Measuring Leg Cutaneous Vascular Conductance - Measured by Laser-doppler Flowmetry of the Skin [Time Frame: 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.]

Secondary ID(s)

1601589496

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

American Heart Association

Results

• Results available: Yes
• Date Posted: 10/02/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02770547