ClinicalTrials.gov
ClinicalTrials.gov Menu

Leg Thermotherapy for Intermittent Claudication

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02770547
Recruitment Status : Recruiting
First Posted : May 12, 2016
Last Update Posted : March 30, 2017
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Raghu Motaganahalli, Indiana University

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.

Condition or disease Intervention/treatment Phase
Peripheral Artery Disease Device: Low Heat Thermotherapy Device: High Heat Thermotherapy Not Applicable

Detailed Description:

Peripheral arterial disease is characterized by atherosclerotic obstruction of the arteries in the lower extremities and affects approximately 10% of individuals older than 65 years. The most common clinical presentation of peripheral arterial disease is intermittent claudication, defined as leg pain caused by insufficient blood flow during walking. Individuals with intermittent claudication have severe exercise intolerance and markedly reduced levels of daily ambulatory activity. It is estimated that up to 40 million people worldwide suffer from intermittent claudication. Despite the increasing prevalence of this condition, few medical therapies improve mobility and exercise tolerance in these patients. An urgent need remains for the development of novel, non-invasive strategies that are more widely accessible and eliminate the need for supervision and frequent traveling to a clinical facility. The 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.

Subjects will complete baseline assessments for eligibility and ability to do study, including medical history, quality of life assessment, ankle-brachial measurement, leg MRI, venous blood draw, assessment of vascular function, and 6-minute walk test. Treatment consists of 3 treatment sessions per week for six consecutive weeks. Subjects will be randomized to low-heat therapy or high-heat therapy. Subjects will wear water-circulating pants through which the heat therapy will be administered during the treatment sessions. Outcome measurements (same as baseline assessments) will be repeated after 9 treatment sessions and after 18 treatment sessions (at the end of the treatment period).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Leg Thermotherapy for Intermittent Claudication
Study Start Date : June 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Active Comparator: Low Heat Thermotherapy
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
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.
Experimental: High Heat Thermotherapy
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
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.



Primary Outcome Measures :
  1. Exercise tolerance assessed by measuring distance (m) walked in 6-minutes [ Time Frame: Two months ]

Secondary Outcome Measures :
  1. Vascular function assessed by leg MRI to measure peak blood flow in popliteal artery (ml/min) [ Time Frame: Two months ]
  2. 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: Two months ]
  3. Vascular function measuring leg cutaneous vascular conductance - measured by laser-doppler flowmetry of the skin [ Time Frame: Two months ]
  4. Vascular function assessed by muscle oxygenation in calf measured with near-infrared spectroscopy during 6 minute walking test [deoxy-Hb+Mb](uM/cm) [ Time Frame: Two months ]
  5. Walking impairment assessed by medical personnel using 0-100 scale; 0 indicating extreme difficulty - 100 indicating no difficulty [ Time Frame: Two months ]
  6. Patient Reported Functional Health and Well-being using 36-item Short Form Health Survey [ Time Frame: Two months ]
  7. Vascular function assessed by blood draw for circulating levels of inflammatory and vasoactive mediators (pg/mL) [ Time Frame: Two months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02770547


Contacts
Contact: Bruno Tesini Roseguini, PhD 765-496-2612 brosegui@purdue.edu
Contact: Ben Maccaby, BS 317-278-3769 bmaccaby@indiana.edu

Locations
United States, Indiana
Indiana University Health Methodist Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Richard L. Roudebush VA Medical Center Recruiting
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
American Heart Association
Investigators
Study Director: Bruno Tesini Roseguini, PhD Purdue University

Responsible Party: Raghu Motaganahalli, Associate Professor, Indiana University
ClinicalTrials.gov Identifier: NCT02770547     History of Changes
Other Study ID Numbers: 1601589496
First Posted: May 12, 2016    Key Record Dates
Last Update Posted: March 30, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Peripheral Arterial Disease
Intermittent Claudication
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases
Signs and Symptoms