RESveratrol To Improve Outcomes in oldeR pEople With PAD (the RESTORE Trial)

Completed · Not applicable · Has a placebo group

Conditions studied: Peripheral Arterial Disease

In brief

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 and natural supplement, specifically targets several impairments associated with walking difficulty and mobility loss in people with PAD.

Key facts

Study ID

NCT02246660

Run by

Northwestern University

People needed

66

Starts

2015-01-01

Expected to finish

2016-09-01

Last updated by the study team

2018-04-30

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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