Leg Thermotherapy for Intermittent Claudication

NCT02770547 | Completed Results DMC

• 1 other identifier: 1601589496
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Peripheral Artery Disease

Outcome Measures

Primary Outcomes (4)

• Exercise Tolerance Assessed by Measuring Distance (m) Walked in 6-minutes

  6-minutes walk test

  Maximal walking distances on a 6mwt were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values.

• Blood Pressure

  Participants have systolic, diastolic and mean blood pressure recording 14 times during baseline, week 3 and week 6 experimental sessions.

  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)

  Blood draw

  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)

  Blood Draw

  Serum total nitrate levels were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values.

Secondary Outcomes (4)

• Vascular Function Assessed by Leg MRI to Measure Peak Blood Flow in Popliteal Artery (ml/s)

  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 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)

  Ankle-brachial index measures 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

  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.

• Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey

  SF-36 questionnaires were administered at weeks 3/6 and 6/6 of the study and compared to baseline values.

Study Arms (2)

Low Heat Thermotherapy

ACTIVE COMPARATOR

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.

Device: Low Heat Thermotherapy

High Heat Thermotherapy

EXPERIMENTAL

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.

Device: High Heat Thermotherapy

Interventions

Low Heat Thermotherapy DEVICE

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.

Low Heat Thermotherapy

High Heat Thermotherapy DEVICE

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.

High Heat Thermotherapy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women with a stable symptomatic claudication for ≥6 months
• Ankle brachial index \<0.9

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead
• American Heart Association: collaborator

Study Sites (2)

Indiana University Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

Richard L. Roudebush VA Medical Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Limitations and Caveats

Some PC-MRI data was unreliable or lost due to errors in the scanning HR monitor. Erroneous data sets were removed, which reduced the power for PC-MRI flow-related variables.

Results Point of Contact

• Title: Bruno Roseguini, Assistant Professor
• Organization: Purdue University

brosegui@purdue.edu

(765) 496-2612

Study Officials

• Bruno Tesini Roseguini, PhD

  Purdue University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 5, 2016
• First Posted: May 12, 2016
• Study Start: May 30, 2016
• Primary Completion: December 14, 2018
• Study Completion: December 14, 2018
• Last Updated: February 10, 2020
• Results First Posted: February 10, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)