Neuromuscular Electrical Stimulation (NMES) in Patients With Intermittent Claudication

NCT02436200 | Completed Results DMC

• 1 other identifier: 14HH1909
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the benefit of a neuromuscular electrical stimulation device in patients suffering from symptoms and effects of lower limb intermittent claudication.

Conditions

Intermittent Claudication; Peripheral Vascular Disease

Keywords

Intermittent Claudication; IC; Peripheral Arterial Disease; Peripheral Vascular Disease; Peripheral Arterial Occlusive Disease

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Initial Walking Distance

  Initial walking distance measured by treadmill For the initial claudication distance measurement, a fixed load treadmill test will be carried out at 3.5 km/h with a 10% gradient. The initial claudication distance (ICD) is the distance walked until the onset of pain.

  Baseline, 6 weeks

• Absolute Walking Distance Measured by Treadmill

  For the absolute claudication distance measurement, a fixed load treadmill test will be carried out at 3.5 km/h with a 10% gradient. The absolute claudication distance (ACD) is the distance walked before the participant is forced to stop due to typical pain.

  Change in baseline treadmill walking distance at 6 weeks

Secondary Outcomes (6)

• Femoral Haemodynamics Measured by Femoral Artery Duplex Ultrasonography

  Change in baseline femoral haemodynamics at 6 weeks

• Laser Doppler Flow Measured by Optical Laser

  Change in baseline flowmetry at 6 weeks

• Symptomatic Scores by Questionnaire

  Change in baseline questionnaire scores at 6 weeks

• Quality of Life Scores Measured by Questionnaire

  Change in baseline quality of life at 6 weeks

• Urine Metabolic Profile

  Change of profile at baseline and at 6 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

Patients receiving neuromuscular electrical stimulation.

Device: Neuromuscular Electrical Stimulation

Interventions

Neuromuscular Electrical Stimulation DEVICE

Revitive IX neuromuscular electrical stimulation device will be given to all participants as per protocol.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All ethnic groups, male or female above the age of 18 years.
• Diagnosis of mild intermittent claudication
• Be of non-childbearing potential; OR using adequate contraception and have a negative urine pregnancy test result within 24 hours if appropriate before using the study device.
• Blood pressure currently under moderate control (\< 160/100mmHg)
• No current foot ulceration

You may not qualify if:

• Patients meeting any of the following criteria are to be excluded:
• Has an unstable condition (eg, psychiatric disorder, a recent history of substance abuse) or otherwise thought to be unreliable or incapable of complying with the study protocol.
• Has diabetes
• Ankle Brachial Pressure Index \> 0.9
• Has any metal implants
• Pregnant
• Has a cardiac pacemaker or defibrillator device
• Has recent lower limb injury or lower back pain
• Has current foot ulceration or other skin ulcers
• Has foot deformities
• Has any disorder that, in the opinion of the Investigator, might interfere with the conduct of the study.

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College London - Charing Cross Hospital

London, Hammersmith, W6 8FS, United Kingdom

Location

Related Publications (1)

• Babber A, Ravikumar R, Onida S, Lane TRA, Davies AH. Effect of footplate neuromuscular electrical stimulation on functional and quality-of-life parameters in patients with peripheral artery disease: pilot, and subsequent randomized clinical trial. Br J Surg. 2020 Mar;107(4):355-363. doi: 10.1002/bjs.11398. Epub 2020 Jan 7.

  PMID: 31912491 DERIVED

MeSH Terms

Conditions

Intermittent Claudication; Peripheral Vascular Diseases; Peripheral Arterial Disease; Peripheral Arterial Occlusive Disease 1

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases

Limitations and Caveats

Small scale pilot study.

Results Point of Contact

• Title: Professor Alun Davies, Professor of Vascular Surgery
• Organization: Imperial College London

a.h.davies@imperial.ac.uk

+44 (0)20 3311 7309

Study Officials

• Alun H Davies, BA BMChB MA

  Imperial College London

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2015
• First Posted: May 6, 2015
• Study Start: December 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: September 29, 2020
• Results First Posted: September 20, 2019

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)