ULCERS - Electrical Stimulation in Diabetic Foot Ulceration

Imperial College London

Status: Completed

Conditions: Diabetes

Treatments: Other: Best Medical Therapy; Device: GEKO device

Study type: Interventional

Funder types: Other

Identifiers

NCT02211495

14HH1901 (Other Identifier)

14/SC/0084

Details and patient eligibility

About

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

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

No device

Active Comparator group

Description:

Treated with best medical therapy

Treatment:

Other: Best Medical Therapy

Device

Experimental group

Description:

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.

Treatment:

Device: GEKO device

Other: Best Medical Therapy