Fisetin to Reduce Senescence and Mobility Impairment in PAD (NCT06399809) | Clinical Trial Compass
RecruitingPhase 2
Fisetin to Reduce Senescence and Mobility Impairment in PAD
United States34 participantsStarted 2024-09-30
Plain-language summary
The investigators propose a pilot randomized trial to gather preliminary data to test the hypothesis that Fisetin will reduce abundance of senescent cells in blood, skeletal muscle, and both subcutaneous and inter muscular adipose tissue and improve 6-minute walk distance in 34 people with peripheral artery disease (PAD). the investigators will determine whether greater declines in abundance of cells with senescent markers are associated with greater improvement in 6-minute walk distance in people with peripheral artery disease. In exploratory analyses, the investigators will assess whether Fisetin reduces interleukin-6 (IL-6) and novel senescent markers in adipose tissue, muscle, and/or blood.
Who can participate
Age range50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. An ankle brachial index (ABI) less than or equal to 0.90 at baseline.
✓. Vascular lab evidence of PAD (such as a toe brachial pressure less than or equal to 0.70 or an ankle brachial index less than or equal to 0.90), or angiographic evidence of PAD defined as at least 70% stenosis of an artery supplying the lower extremities.
✓. An ABI of greater than 0.90 and less than or equal to 1.00 who experience a 20% or greater drop in ABI in either leg after the heel-rise test will also be included.
Exclusion criteria
✕. Above- or below-knee amputation
✕. Critical limb ischemia defined as an ABI less than 0.40 with signs or symptoms of critical limb ischemia
✕. Wheelchair confinement or requiring a walker to ambulate
✕. Walking is limited by a symptom other than PAD
✕. Current foot ulcer on bottom of foot
✕. Failure to successfully complete the study run-in
What they're measuring
1
Six-minute Walk Distance
Timeframe: Measured at baseline and 4 month follow-up