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ULCERS - Electrical Stimulation in Diabetic Foot Ulceration

NCT ID: NCT02211495

Last Updated: 2020-11-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-12-31

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.

Conditions

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Diabetes

Keywords

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Diabetic Foot Ulcer healing Medical device to increase blood flow in foot

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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No device

Treated with best medical therapy

Group Type ACTIVE_COMPARATOR

Best Medical Therapy

Intervention Type OTHER

Seen in outpatient clinic for wound care and ongoing advice

Device

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.

Group Type EXPERIMENTAL

GEKO device

Intervention Type DEVICE

Placed on the lateral aspect of the knee, when activated it causes the leg to twitch

Best Medical Therapy

Intervention Type OTHER

Seen in outpatient clinic for wound care and ongoing advice

Interventions

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GEKO device

Placed on the lateral aspect of the knee, when activated it causes the leg to twitch

Intervention Type DEVICE

Best Medical Therapy

Seen in outpatient clinic for wound care and ongoing advice

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 18+ years old
* Type 2 diabetes on best medical therapy

Exclusion Criteria

* Pregnancy
* Pacemaker
* Metal implants in the legs (below knee)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kate Williams

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

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Diabetic Foot Clinic, Praed Street, Paddington

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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14HH1901

Identifier Type: OTHER

Identifier Source: secondary_id

14/SC/0084

Identifier Type: -

Identifier Source: org_study_id