NCT02136537

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 13, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

May 9, 2019

Status Verified

May 1, 2019

Enrollment Period

2.3 years

First QC Date

May 9, 2014

Last Update Submit

May 8, 2019

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

  • Absolute walking distance

    Treadmill test (2mph, 0% grade increased by 3.5% every 3 minutes to a maximum of 15%

    6 weeks

Secondary Outcomes (1)

  • Claudication distance

    6 weeks

Study Arms (2)

Best medical therapy

ACTIVE COMPARATOR

Claudicants treated according to local protocol - no added treatment

Other: Best medical therapy

Best medical therapy plus NMES

EXPERIMENTAL

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

Device: Bilateral NMES legsOther: Best medical therapy

Interventions

Bilateral NMES legsDEVICE

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

Best medical therapy plus NMES
Best medical therapyOTHER

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.

Best medical therapyBest medical therapy plus NMES

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of stable intermittent claudication (\>6 months) with confirmation by medical imaging
  • ABPI\<0.9
  • Absolute walking distance \<500m

You may not qualify if:

  • Pregnancy
  • Cardiac pacemaker
  • Previous lower limb major amputation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charing Cross Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Officials

  • AH Davies

    Imperial College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2014

First Posted

May 13, 2014

Study Start

August 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

May 9, 2019

Record last verified: 2019-05

Locations

GB(1)