Status:
COMPLETED
RESveratrol To Improve Outcomes in oldeR pEople With PAD (the RESTORE Trial)
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
The RESTORE trial will determine whether resveratrol supplementation can improve walking performance in older people with lower extremity peripheral arterial disease (PAD). Resveratrol, a polyphenol a...
Detailed Description
Eight million men and women in the United States have lower extremity peripheral arterial disease (PAD). PAD is expected to be increasingly common as the population survives longer with chronic diseas...
Eligibility Criteria
Inclusion
- Ankle-brachial index (ABI) \< 0.90 at baseline screening (at visit), or, medical evidence of prior lower extremity revascularization if ABI ≥ 0.90.
- 65 or older
Exclusion
- Above/below-knee amputation, critical limb ischemia, wheelchair-bound, or require the use of a walker or cane
- Other symptom(s) limiting walking ability, other than PAD
- Underwent/experienced lower extremity revascularization, a cardiovascular event, or coronary artery bypass surgery within 3 months of screening. Underwent major orthopedic surgery within 6 months of screening. Planning to have revascularization or major elective surgery within the next 6 months.
- Major medical illness including renal disease that requires dialysis or lung disease that requires oxygen
- Score of \< 23 on Mini-Mental Status Examination at screening or major psychiatric illness
- Currently participating in a separate clinical trial
- Significant renal or liver dysfunction at baseline
- Does not successfully complete the study run-in period
- Has an extreme baseline 6 minute walk value (\< 500 ft or \> 1,600 feet )
- Treated for cancer during the last 2 years (unless prognosis is excellent)
- Severe hearing impairment or other communication difficulties (e.g. non-English speaking) or legally blind
- Diagnosis of Parkinson's disease
- Unable to return to medical center at required visit frequency
- Otherwise poorly suited to intervention (at the discretion of the PI)
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT02246660
Start Date
January 1 2015
End Date
September 1 2016
Last Update
April 30 2018
Active Locations (1)
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1
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611