Electrical Stimulation in Peripheral Arterial Disease (PAD)

Imperial College London

Status: Terminated

Conditions: Peripheral Arterial Disease

Treatments: Other: Best medical therapy; Device: Bilateral NMES legs

Study type: Interventional

Funder types: Other

Identifiers

NCT02136537

14HH2054 (Other Identifier)

14/LO/0854

Details and patient eligibility

About

The investigators wish to investigate the effects of neuromuscular stimulation on intermittent claudication.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of stable intermittent claudication (>6 months) with confirmation by medical imaging
• ABPI<0.9
• Absolute walking distance <500m

Exclusion criteria

• Pregnancy
• Cardiac pacemaker
• Previous lower limb major amputation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Best medical therapy

Active Comparator group

Description:

Claudicants treated according to local protocol - no added treatment

Treatment:

Other: Best medical therapy

Best medical therapy plus NMES

Experimental group

Description:

In addition to best medical therapy, subjects will receive bilateral neuromuscular stimulation of their legs, 4 hours per day.

Treatment:

Other: Best medical therapy

Device: Bilateral NMES legs