Actively Recruiting
Fisetin to Reduce Senescence and Mobility Impairment in Peripheral Artery Disease: the FIRST Pilot Randomized Trial
Led by Northwestern University · Updated on 2026-04-15
34
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a pilot randomized trial to study whether Fisetin, a natural flavanol found in fruits like strawberries and apples, can reduce the number of aging cells (senescent cells) in blood, muscle, and fat tissues of people with peripheral artery disease (PAD). The study also aims to see if reducing these cells improves walking ability measured by the six-minute walk test. Additionally, the trial will explore if Fisetin lowers inflammation markers such as interleukin-6 and other senescence-related markers. Participants aged 50 and older with PAD will be randomly assigned to receive either Fisetin or a placebo. The treatment involves taking Fisetin or placebo capsules at a dose of 20 mg per kg of body weight once daily for two days, followed by 12 days without treatment, repeated over a four-month period. The capsules are provided in 100 mg tablets, with dosing rounded to the nearest 100 mg. During the study, participants will undergo assessments at the start and after four months, including tests of walking distance, hand grip strength, physical performance, muscle blood flow, and cell markers of aging. Researchers will monitor these measures to evaluate changes and safety throughout the trial period. The total study duration for each participant is four months, during which their health and response to the treatment will be closely followed.
CONDITIONS
Brief Title
Fisetin to Reduce Senescence and Mobility Impairment in PAD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be age 50 or older
- Diagnosis of peripheral artery disease (PAD) confirmed by ankle brachial index (ABI) ≤ 0.90, vascular lab evidence, or angiographic evidence of at least 70% artery narrowing
- Participants with ABI > 0.90 and ≤ 1.00 who have a 20% or greater drop in ABI after heel-rise test are included
You will not qualify if you...
- Above- or below-knee amputation
- Critical limb ischemia with ABI < 0.40 and symptoms
- Wheelchair confinement or need for walker to walk
- Walking limited by causes other than PAD
- Current foot ulcer on bottom of foot
- Failure to complete study run-in phase
- Planned major surgery or revascularization within 5 months
- Major surgery, revascularization, or cardiovascular event within past 3 months
- Major illnesses such as lung disease needing oxygen, Parkinson's, life-threatening illness with less than 6 months expectancy, or recent cancer treatment
- Mini-Mental Status Exam score below 23
- Allergy or recent use of fisetin
- Non-English speakers
- Recent participation in other clinical trials
- Visual impairment limiting walking ability
- Six-minute walk distance less than 500 feet or more than 1600 feet
- Participation in supervised treadmill exercise program in past 3 months
- Possible exclusion for refusal of fat biopsy
- Women who are not menopausal
- High bilirubin or liver enzyme levels
- Severe blood count abnormalities
- Low kidney function (eGFR < 25)
- Poor diabetes control (HbA1C > 10)
- HIV positive or active hepatitis B or C with high viral load
- Use of certain blood-thinning drugs that cannot be stopped around dosing
- Body mass index over 43
- Investigator discretion for safety or suitability concerns
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 months
Participants receive either Fisetin or placebo dosing cycles to reduce senescent cells and improve mobility.
Repeated dosing every 14 days with 2 days of medication followed by 12 days off, over 4 months
Duration - Up to 4 months total including treatment period
Participants are assessed for changes in walk distance, strength, and cellular markers after treatment ends.
Baseline and 1 follow-up visit at 4 months
Trial Site Locations
Total: 1 location
1
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611-3008
Actively Recruiting
Research Team
M
Mary McDermott, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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