Clinical trial NCT02211495: ULCERS - Electrical Stimulation in Diabetic Foot Ulceration
Official title: Electrical Stimulation in Diabetic Foot Ulceration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Diabetic Foot
Ulcer healing
Medical device to increase blood flow in foot
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2014-08-07
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed 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.

Eligibility 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)

Primary outcomes:
measure: Number of Day Until 50% Healing of Leg Ulcer
timeFrame: 8 weeks
Secondary outcomes:
measure: Quality of Life (PAID, EQ5D, VAS, SF-12)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Diabetic Foot Clinic, Praed Street, Paddington
Study officials:
affiliation: Imperial College London
name: Kate Williams
role: PRINCIPAL_INVESTIGATOR
References: