ULCERS - Electrical Stimulation in Diabetic Foot Ulceration

Diabetes Clinical Trial

Official title:

Electrical Stimulation in Diabetic Foot Ulceration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02211495
• Other study ID #: 14/SC/0084
• Secondary ID: 14HH1901
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: December 2015

Study information

• Verified date: November 2020
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators hypothesise that use of a medical device, that increases blood flow to the foot, will speed up ulcer healing in symptomatic diabetes

Description:

Diabetes affects approximately 347 million people worldwide, and by 2030 the WHO projects that diabetes will be the 7th leading cause of death. Diabetic foot ulcers are estimated to occur in 15% of all patients with diabetes, often co-existing with neuropathy and peripheral vascular disease which compromise the limb's ability to heal. Foot infections in this cohort are common, and diabetic foot ulcers serve as a portal for infective organisms to enter the body. Unchecked, infection can spread contiguously to involve underlying tissues, including bone. A diabetic foot infection is often the pivotal event leading to gangrene and lower extremity amputation. Diabetes accounts for over one million leg amputations every year, and represents 60% of all amputations in developed countries.

Due to the potential for rapid progression of infection, and the gravity of potential complications, diabetic foot problems are handled aggressively in the community, with a low threshold for referral to secondary care. Out-patient clinics involve a multidisciplinary team of clinicians, podiatrists and vascular surgeons. Good foot care is taught to all diabetic patients, and treatment with antibiotics, debridement and revascularisation should occur as a matter of urgency where appropriate.

The device to be tested mimics the effect of walking by making the foot twitch- it increases blood flow to the limb and exercises the leg muscles. It is hypothesised that increasing blood flow to the limb, much as surgical revascularisation, will aid the legs ability to heal and fight infection. After training, it can be used by patients on themselves and is suitable for out-patient therapy.

The investigators wish to evaluate both the short- and longer-term effects of a neuromuscular stimulator on diabetic foot ulceration as a therapeutic intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria

• 18+ years old

• Type 2 diabetes on best medical therapy

• Active foot ulceration, present <3 months Exclusion criteria

• Pregnancy

• Pacemaker

• Metal implants in the legs (below knee)

Related Conditions & MeSH terms

• Diabetes
• Diabetic Foot
• Foot Ulcer

Intervention

Device:
• GEKO device
Placed on the lateral aspect of the knee, when activated it causes the leg to twitch

Other:
• Best Medical Therapy
Seen in outpatient clinic for wound care and ongoing advice

Locations

Country	Name	City	State
United Kingdom	Diabetic Foot Clinic, Praed Street, Paddington	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Day Until 50% Healing of Leg Ulcer	Time to 50% healing of leg ulcer, as measured by volume (3D camera)	8 weeks
Secondary	Quality of Life (PAID, EQ5D, VAS, SF-12)	Improvement in quality of life questionnaire values, comparing baseline to 6 weeks with treatment PAID ("Problem Areas in Diabetes") - score 0-80, 0 is no problem, 80 is serious problem EQ5D (standardised instrument for generic quality of life score, https://en.wikipedia.org/wiki/EQ-5D) - combination of different dimensions of health to form an overall index, 1.0 for a perfect state of health, with 0 on the scale representing the state of being dead VAS ("visual analogue scale") - For pain intensity, the scale is anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100) SF 12 ("short form 12") - weighted and summed to provide easily interpretable scales for physical and mental health, the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health	6 weeks