Your session is about to expire
← Back to Search
Anti-aging Agent
Fisetin for PAD (FIRST Trial)
Phase 2
Recruiting
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Vascular lab evidence of PAD (such as a toe brachial pressure < 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 >0.90 and <=1.00 who experience a 20% or greater drop in ABI in either leg after the heel-rise test will also be included.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at baseline and 4 months
Summary
This trial aims to test if Fisetin can reduce senescent cells in different parts of the body and improve walking distance in people with peripheral artery disease. They will also see if the reduction in
Who is the study for?
This trial is for people with peripheral artery disease (PAD), which can cause limited mobility and difficulty walking. Participants must have specific vascular lab evidence of PAD or a drop in ABI after the heel-rise test. It's not suitable for those who don't meet these criteria.
What is being tested?
The study tests if Fisetin, a compound thought to reduce cell aging, can decrease senescent cells and improve walking distance over six minutes compared to a placebo. The effects on inflammation markers and other aging indicators will also be explored.
What are the potential side effects?
Potential side effects are not detailed here but could include reactions similar to other supplements or medications aimed at reducing cellular aging or inflammation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with PAD based on vascular tests or angiography.
Select...
My ABI is between 0.90 and 1.00, and it drops by 20% or more after a physical test.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured at baseline and 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at baseline and 4 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Six-minute Walk Distance
Secondary study objectives
Gastrocnemius perfusion
Hand Grip Strength
Number of cells with senescence markers
+1 moreOther study objectives
Abundance of cells with central nuclei
Abundance of cells with increased myofiber size
Abundance of interleukin-6 markers
+4 moreSide effects data
From 2023 Phase 1 & 2 trial • 75 Patients • NCT0421098638%
Arthralgia
15%
Pain in Extremity
12%
Lab Findings
12%
Nausea
9%
Fatigue
9%
Back Pain
9%
Headache
6%
Muscle Cramp
6%
Flatulence
6%
Dry Mouth
6%
Rash Maculo-Papular
3%
Covid 19
3%
Bladder Perforation
3%
Neoplasms
3%
Rotator Cuff Injury
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fisetin
Placebo
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: FisetinExperimental Treatment1 Intervention
Sharp Clinical Services will provide fisetin (100 mg capsules). Randomized participants will receive fisetin 20 mgs/kg once daily for two days, followed by 12 days without therapy. Fisetin will be dosed in 100 mg tablets. Dosing will be rounded to the nearest 100 mg. For example, a 73 kg participant with a dose of 1,460 mg (i.e.73 kg x 20 mg) receives 1,500 mgs daily (i.e. 15 x 100 mg capsules) for two days every 14 days.
Group II: PlaceboPlacebo Group1 Intervention
Sharp Clinical Services will provide placebo (100 mg capsules). Randomized participants will receive placebo 20 mgs/kg once daily for two days, followed by 12 days without therapy. Placebo will be dosed in 100 mg tablets. Dosing will be rounded to the nearest 100 mg. For example, a 73 kg participant with a dose of 1,460 mg (i.e.73 kg x 20 mg) receives 1,500 mgs daily (i.e. 15 x 100 mg capsules) for two days every 14 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fisetin
2016
Completed Phase 2
~250
Find a Location
Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,652 Previous Clinical Trials
961,481 Total Patients Enrolled