Leg Thermotherapy for Intermittent Claudication
Condition: Peripheral Artery Disease
MeSH terms: Peripheral Arterial Disease; Intermittent Claudication
Study type: Interventional

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.
    

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).
    

Intervention name(s): Low Heat Thermotherapy; High Heat Thermotherapy
Intervention type(s): Device; Device
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment