Neuromuscular Electrical Stimulation in Patients With Critical Limb Ischaemia

NCT02634138 | Terminated DMC

• 1 other identifier: 14HH2036
• Study Type: interventional
• Target: 4
• 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 critical limb ischaemia.

Conditions

Peripheral Arterial Disease; Critical Limb Ischaemia

Keywords

Peripheral Vascular Disease; Critical Limb Ischaemia

Outcome Measures

Primary Outcomes (1)

• Pain Score

  Change in pain score with device use over a 6 week period. Measure by a visual analogue scale of pain with 0 = no pain and 10 = maximum pain

  6 weeks

Secondary Outcomes (7)

• Major amputation rate

  6 weeks

• Flow rate in Femoral Artery

  Day 1 then at 6 weeks

• Femoral artery diameter

  Day 1 and at 6 weeks

• Disease specific questionnaire - VascuQoL

  Day 1 and at 6 weeks

• Short Form - 36 (SF-36)

  Day 1 and at 6 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

Revitive IX Neuromuscular Electrical Stimulation Device

Device: Revitive IX

Interventions

Revitive IX DEVICE

A foot plate Neuromuscular Electrical Stimulation Device

Intervention

Eligibility Criteria

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

You may qualify if:

• Willing, able, and committed to participate in the procedures for the full length of the study.
• All ethnic groups, male or female above the age of 18 years.
• Diagnosis of non-reconstructable arterial disease and critical limb ischaemia (with a minimum of duplex ultrasound and an MDT discussion to have reached this diagnosis)
• 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)
• History of uncomplicated cardiovascular events beyond 3 months.
• 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 any metal implants
• Pregnant
• Has peripheral neuropathy
• 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
• Ankle-Brachial Pressure Index \>0.9

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College London - Charing Cross Hospital

London, W6 8RF, United Kingdom

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia; Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Alun H Davies, BA BMChB MA

  Imperial College London

  STUDY CHAIR

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: December 1, 2015
• First Posted: December 17, 2015
• Study Start: November 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: June 6, 2019

Record last verified: 2019-06

Locations

GB (1)