Saving Life and Limb: FES for the Elderly With PAD

Completed · Phase 1

Conditions studied: Peripheral Arterial Disease

In brief

This study will take the first step to improve public health for millions of Americans with Peripheral Arterial Disease who have extreme difficulty walking due to leg pain. The investigators will assess a proof of concept, home administered, functional electrical stimulation (FES) system to resolve pain, improve walking, and enhance quality of life.

Key facts

Study ID

NCT02384980

Run by

MultiCare Health System Research Institute

People needed

43

Starts

2014-09-01

Expected to finish

2016-05-01

Last updated by the study team

2016-08-16

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who:
• Are ambulatory, community dwelling adults with evidence of PAD including ankle/brachial index ABI=0.4-0.9
• Have symptom severity of Fontaine stage II-III
• Have a score of 24 or higher on the Folstein Mini Mental test
• Have visible muscle contraction of the plantar flexor (PF) and dorsiflexor (DF) muscles using FES

You may not qualify if…

• Patients who:
• Have an electronic implanted stimulator such as pacemaker, defibrillator, deep brain stimulator, spinal cord stimulator
• Are pregnant
• Cannot walk without a walker or require human assistance to walk,
• Present with arthritis or neurological damage resulting in paresis or paralysis of the lower extremity
• Have skin lesion(s) on the legs where the FES is placed

Where it is running

• MultiCare Health System — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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