Electrical Stimulation in Peripheral Arterial Disease

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02136537

Acronym

PAD

Enrollment

Registered

2014-05-13

Start date

2014-08-31

Completion date

2016-12-31

Last updated

2019-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Disease

Brief summary

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

Interventions

DEVICEBilateral NMES legs

Stimulation with the geko(TM) device, Firstkind Ltd, UK. 4 hours per day, bilateral, applied to the skin overlying the common peroneal nerve

OTHERBest medical therapy

Treated according to local NHS protocol. At Imperial College Healthcare Trust, this will include diagnostic tests (medical interview and examination, ultrasound of blood vessels, diagnostic treadmill test, blood tests and Xrays as appropriate). This also includes lifestyle advice, treatment with appropriate drugs such as aspirin and statins, and supervised exercise.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Absolute walking distance	6 weeks	Treadmill test (2mph, 0% grade increased by 3.5% every 3 minutes to a maximum of 15%

Secondary

Measure	Time frame	Description
Claudication distance	6 weeks	Treadmill test (as per absolute walking distance)

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026