Actively Recruiting

Phase 2
Age: 50Years +
All Genders
NCT06399809

Fisetin to Reduce Senescence and Mobility Impairment in PAD

Led by Northwestern University · Updated on 2026-04-15

34

Participants Needed

1

Research Sites

139 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Fisetin to Reduce Senescence and Mobility Impairment in PAD

Who Can Participate

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 50 years or older
  • Diagnosis of peripheral artery disease (PAD) defined by one of the following:
    1. Ankle brachial index (ABI) less than or equal to 0.90 at baseline
    2. Vascular lab evidence of PAD (e.g., toe brachial pressure ≤ 0.70 or ABI ≤ 0.90)
    3. Angiographic evidence of at least 70% artery narrowing supplying the lower limbs
    4. ABI greater than 0.90 but ≤ 1.00 with a 20% or greater drop in ABI after heel-rise test
  • Willingness to participate and follow study procedures
Not Eligible

You will not qualify if you...

  • Above- or below-knee amputation
  • Critical limb ischemia with ABI less than 0.40 and symptoms
  • Wheelchair confinement or need for a walker
  • Walking limited by causes other than PAD
  • Current foot ulcer on the bottom of the foot
  • Failure to complete the study run-in phase
  • Planned major surgery or revascularization within five months
  • Major surgery, revascularization, or cardiovascular event in the last three months
  • Serious medical illnesses such as lung disease needing oxygen, Parkinson's disease, life-threatening illness with life expectancy under six months, or recent cancer treatment (except early-stage with excellent prognosis)
  • Mini-Mental Status Examination (MMSE) score below 23
  • Allergy to fisetin
  • Current or recent (past three months) fisetin use
  • Non-English speaking
  • Recent participation in another clinical trial intervention (past three months) with specific rules for stem cell or gene therapy
  • Visual impairment limiting walking
  • Six-minute walk distance under 500 feet or over 1600 feet
  • Participation in supervised treadmill exercise in the past three months
  • Possible exclusion for unwillingness to undergo fat biopsy
  • Women who are not menopausal (no menstrual period in past 12 months)
  • Elevated bilirubin, liver enzymes, or abnormal blood counts
  • Severe kidney dysfunction (eGFR < 25 ml/min/1.73 m2)
  • Poor diabetes control (Hemoglobin A1C > 10)
  • HIV positive or active hepatitis B or C with high viral load
  • Use of certain blood-thinning or sensitive drugs unless held around dosing
  • Body mass index (BMI) over 43
  • Investigator discretion based on safety or fit for trial participation

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States, 60611-3008

Actively Recruiting

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Research Team

M

Mary McDermott, MD

CONTACT

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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