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Electrical Stimulation in Peripheral Arterial Disease (PAD)

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ClinicalTrials.gov Identifier: NCT02136537
Recruitment Status : Terminated (Member of staff moved on to training post. Trial halted and terminated)
First Posted : May 13, 2014
Last Update Posted : April 15, 2016
Sponsor:
Information provided by (Responsible Party):
Imperial College London

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

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Device: Bilateral NMES legs Other: Best medical therapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Electrical Stimulation in Peripheral Arterial Disease
Study Start Date : August 2014
Estimated Primary Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Best medical therapy
Claudicants treated according to local protocol - no added treatment
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.

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




Primary Outcome Measures :
  1. Absolute walking distance [ Time Frame: 6 weeks ]
    Treadmill test (2mph, 0% grade increased by 3.5% every 3 minutes to a maximum of 15%


Secondary Outcome Measures :
  1. Claudication distance [ Time Frame: 6 weeks ]
    Treadmill test (as per absolute walking distance)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02136537


Locations
United Kingdom
Charing Cross Hospital
London, United Kingdom
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: AH Davies Imperial College London

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT02136537     History of Changes
Other Study ID Numbers: 14/LO/0854
14HH2054 ( Other Identifier: Imperial College JRCO )
First Posted: May 13, 2014    Key Record Dates
Last Update Posted: April 15, 2016
Last Verified: November 2015

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases