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

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwestern University
• Collaborator: National Institute on Aging (NIA)
• Treatments: Resveratrol

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)