Project VOICE: Vascular Outcomes Improvement Through Collection of PatiEnt Reported Data

Completed · Not applicable

Conditions studied: Peripheral Artery Disease

In brief

The purpose of this study is to evaluate the feasibility of a digital health platform coupled with walking activity tracking for patients with Peripheral Artery Disease (PAD) and symptoms limited to claudication.

Key facts

Study ID

NCT03554564

Run by

University of Michigan

People needed

28

Starts

2018-08-02

Expected to finish

2019-11-13

Last updated by the study team

2019-11-29

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Clinical diagnosis of symptomatic PAD with claudication
• Ankle- brachial index (ABI) ≤ 0.9 or non-compressible leg arteries
• Walking exercise therapy recommended as treatment for PAD by the healthcare provider
• Willingness to be randomized to VOICE platform or control group
• Ability to access the internet
• Willing to sign an informed consent

You may not qualify if…

• Walking exercise therapy not recommended due to contraindication or any other reason
• Wheelchair dependence or inability to walk unassisted
• Presence of foot ulcers, wounds, or gangrene
• History of major extremity amputation
• Lack of objective physiologic data validating PAD diagnosis
• Claudication symptoms due to diagnoses other than PAD (i.e., popliteal entrapment syndrome)
• Inability to speak or read English
• Severe mental illness
• Inability to give informed consent

Where it is running

• University of Michigan - Vascular Surgery Section — Ann Arbor, Michigan, United States
• Wake Forest Baptist Health — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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