Leg Thermotherapy for Intermittent Claudication
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|ClinicalTrials.gov Identifier: NCT02770547|
Recruitment Status : Recruiting
First Posted : May 12, 2016
Last Update Posted : May 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Artery Disease||Device: Low Heat Thermotherapy Device: High Heat Thermotherapy||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Leg Thermotherapy for Intermittent Claudication|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2020|
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.
- Exercise tolerance assessed by measuring distance (m) walked in 6-minutes [ Time Frame: Two months ]
- Vascular function assessed by leg MRI to measure peak blood flow in popliteal artery (ml/min) [ Time Frame: Two months ]
- 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 ]
- Vascular function measuring leg cutaneous vascular conductance - measured by laser-doppler flowmetry of the skin [ Time Frame: Two months ]
- 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 ]
- Walking impairment assessed by medical personnel using 0-100 scale; 0 indicating extreme difficulty - 100 indicating no difficulty [ Time Frame: Two months ]
- Patient Reported Functional Health and Well-being using 36-item Short Form Health Survey [ Time Frame: Two months ]
- Vascular function assessed by blood draw for circulating levels of inflammatory and vasoactive mediators (pg/mL) [ Time Frame: Two months ]
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
|Contact: Bruno Tesini Roseguini, PhDfirstname.lastname@example.org|
|Contact: Ben Maccaby, BSemail@example.com|
|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|
|Study Director:||Bruno Tesini Roseguini, PhD||Purdue University|