- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02770547
Leg Thermotherapy for Intermittent Claudication
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Indiana University Health Methodist Hospital
-
Indianapolis, Indiana, United States, 46202
- Richard L. Roudebush VA Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
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.
|
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)
Time Frame: Serum endothelin-1 levels were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values.
|
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)
Time Frame: Serum total nitrate levels were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values.
|
Blood Draw
|
Serum total nitrate levels were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Phase contrast magnetic resonance imaging was performed on the leg that the patient indicated to have the most severe claudication.
An inflation cuff was placed around the thigh and inflated to 75 mmHg above resting brachial systolic pressure for 5 minutes.
After 5 minutes of inflation, the cuff was release and an additional 10 minutes of imaging took place.
|
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)
Time Frame: Ankle-brachial index measures were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values.
|
Ankle-brachial Index
|
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
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.
|
Laser-Doppler flowmetry of skin included placement of two heating probes on the anterior portion of the lower leg.
The participant sat in a semi-recumbent position for 70 minutes while the temperature of the probe progressed from 33C to 39C at minute 10 and then to 43C at minute 50.
Cutaneous vascular conductance was calculated at the average red blood cell flux during the final 2 minutes of the 39C heating portion divided by the mean arterial pressure taken at that time.
|
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
Time Frame: SF-36 questionnaires were administered at weeks 3/6 and 6/6 of the study and compared to baseline values.
|
36-item Short Form Health Survey.
All scales are scored 1-100, with 1 being the poorest rating and 100 being the most optimal.
|
SF-36 questionnaires were administered at weeks 3/6 and 6/6 of the study and compared to baseline values.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Bruno Tesini Roseguini, PhD, Purdue University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1601589496
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Peripheral Artery Disease
-
Janssen Scientific Affairs, LLCHCA Research Institute, LLCRecruitingCoronary Artery Disease (CAD) | Peripheral Artery Disease (PAD)United States
-
University of NebraskaNot yet recruitingPeripheral Arterial Disease | Peripheral Vascular Disease | Peripheral Artery Disease | Peripheral Artery Occlusive DiseaseUnited States
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedStructural Heart Disease | Obstructive Coronary Artery Disease | Obstructive Peripheral Artery DiseaseUnited States
-
Helsinki University Central HospitalCompletedPeripheral Artery Occlusive Disease | Peripheral Artery Stenosis | Peripheral Artery RestenosisFinland
-
Michael Lichtenberg, MDCompletedPeripheral Artery Disease (PAD)Germany
-
Fangge DengRecruitingPeripheral Artery Disease (PAD)China
-
Fundacion para la Formacion e Investigacion Sanitarias...Not yet recruiting
-
Rontis Hellas SAPharmassist LtdActive, not recruitingPeripheral Artery Disease (PAD)Greece
-
Boston Scientific CorporationCompletedAtherosclerosis | Peripheral Artery Disease | Plaque, Atherosclerotic | Artery Diseases, Peripheral | Occlusive Arterial DiseaseUnited States, Belgium, Canada, Japan, Austria, New Zealand
-
Seung-Whan Lee, M.D., Ph.D.Active, not recruitingCatheterization, Peripheral | Popliteal Artery | Angioplasty, Balloon | Femoral ArteryKorea, Republic of
Clinical Trials on Low Heat Thermotherapy
-
Riphah International UniversityCompletedKnee Osteoarthritis | Type II DiabetesPakistan
-
Roswell Park Cancer InstituteWithdrawnHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid NeoplasmUnited States
-
dorsaVi LtdMonash UniversityCompleted
-
University Hospital HeidelbergCentre Suisse de Recherches Scientifiques en Cote d'Ivoire; Institut Pasteur...RecruitingSkin Ulcer | Nontuberculous Mycobacteria | Buruli UlcerCôte D'Ivoire
-
Region Örebro CountyRecruitingCardiac Rehabilitation | Cardiac DiseaseSweden
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Hvidovre University HospitalLundbeck FoundationTerminated
-
Chronic Obstructive Pulmonary Disease Trial Network...RecruitingBronchiectasis | Lung Diseases, Obstructive | Chronic Obstructive Pulmonary Disease | Asthma | Copd | Chronic Lung InfectionsDenmark
-
Far Eastern Memorial HospitalRecruitingLaser Thermotherapy, Stress Urinary IncontinenceTaiwan
-
Alexandria UniversityCompletedMuscle DisorderEgypt