Back to resultsElectrical Stimulation in Peripheral Arterial Disease (PAD)
Primary Purpose
Peripheral Arterial Disease
Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Bilateral NMES legs
Best medical therapy
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Arterial Disease
Eligibility 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
Sites / Locations
- Charing Cross Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Best medical therapy
Best medical therapy plus NMES
Arm Description
Claudicants treated according to local protocol - no added treatment
In addition to best medical therapy, subjects will receive bilateral neuromuscular stimulation of their legs, 4 hours per day.
Outcomes
Primary Outcome Measures
Absolute walking distance
Treadmill test (2mph, 0% grade increased by 3.5% every 3 minutes to a maximum of 15%
Secondary Outcome Measures
Claudication distance
Treadmill test (as per absolute walking distance)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02136537
Brief Title
Electrical Stimulation in Peripheral Arterial Disease
Acronym
PAD
Official Title
Electrical Stimulation in Peripheral Arterial Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Why Stopped
Member of staff moved on to training post. Trial halted and terminated
Study Start Date
August 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators wish to investigate the effects of neuromuscular stimulation on intermittent claudication.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Best medical therapy
Arm Type
Active Comparator
Arm Description
Claudicants treated according to local protocol - no added treatment
Arm Title
Best medical therapy plus NMES
Arm Type
Experimental
Arm Description
In addition to best medical therapy, subjects will receive bilateral neuromuscular stimulation of their legs, 4 hours per day.
Intervention Type
Device
Intervention Name(s)
Bilateral NMES legs
Intervention Description
Stimulation with the geko(TM) device, Firstkind Ltd, UK. 4 hours per day, bilateral, applied to the skin overlying the common peroneal nerve
Intervention Type
Other
Intervention Name(s)
Best medical therapy
Intervention Description
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 Measure Information:
Title
Absolute walking distance
Description
Treadmill test (2mph, 0% grade increased by 3.5% every 3 minutes to a maximum of 15%
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Claudication distance
Description
Treadmill test (as per absolute walking distance)
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AH Davies
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charing Cross Hospital
City
London
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Electrical Stimulation in Peripheral Arterial Disease
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