Electrical Stimulation in Peripheral Arterial Disease (PAD)

This study has been terminated.
(Member of staff moved on to training post. Trial halted and terminated)
Sponsor:
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT02136537
First received: May 9, 2014
Last updated: April 14, 2016
Last verified: November 2015
  Purpose
The investigators wish to investigate the effects of neuromuscular stimulation on intermittent claudication.

Condition Intervention
Peripheral Arterial Disease
Device: Bilateral NMES legs
Other: Best medical therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Electrical Stimulation in Peripheral Arterial Disease

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Absolute walking distance [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Treadmill test (2mph, 0% grade increased by 3.5% every 3 minutes to a maximum of 15%


Secondary Outcome Measures:
  • Claudication distance [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Treadmill test (as per absolute walking distance)


Enrollment: 40
Study Start Date: August 2014
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02136537

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

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT02136537     History of Changes
Other Study ID Numbers: 14/LO/0854  14HH2054 
Study First Received: May 9, 2014
Last Updated: April 14, 2016
Health Authority: United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on May 26, 2016