ULCERS - Electrical Stimulation in Diabetic Foot Ulceration

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

Detailed Description
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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.

Official Title
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Electrical Stimulation in Diabetic Foot Ulceration

Conditions
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Diabetes

Intervention / Treatment
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* Device: GEKO device
* Other: Best Medical Therapy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: No device<br>Treated with best medical therapy | Other: Best Medical Therapy<br>* Seen in outpatient clinic for wound care and ongoing advice<br>|
| Experimental: Device<br>As well as receiving best medical therapy, these people will be given the geko device to wear on their affected leg. They will wear it for 4 hours per day, 5 days a week. | Device: GEKO device<br>* Placed on the lateral aspect of the knee, when activated it causes the leg to twitch<br>Other: Best Medical Therapy<br>* Seen in outpatient clinic for wound care and ongoing advice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Foot, Ulcer healing, Medical device to increase blood flow in foot