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NCT02136537 Clinical Trial

Electrical Stimulation in Peripheral Arterial Disease

Peripheral Arterial Disease Clinical Trial

— PAD  

Official title:
Electrical Stimulation in Peripheral Arterial Disease

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02136537
Other study ID # 14/LO/0854
Secondary ID 14HH2054
Status Terminated
Phase N/A
First received
Last updated
Start date August 2014
Est. completion date December 2016

Study information
Verified date May 2019
Source Imperial College London
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Terminated
Enrollment 40
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Bilateral 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
Other:
• Best 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.

Locations
Country Name City State
United Kingdom Charing Cross Hospital London

Sponsors (1)
Lead Sponsor Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Absolute walking distance Treadmill test (2mph, 0% grade increased by 3.5% every 3 minutes to a maximum of 15% 6 weeks
Secondary Claudication distance Treadmill test (as per absolute walking distance) 6 weeks
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