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ULCERS - Electrical Stimulation in Diabetic Foot Ulceration

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ClinicalTrials.gov Identifier: NCT02211495
Recruitment Status : Completed
First Posted : August 7, 2014
Results First Posted : November 4, 2020
Last Update Posted : November 20, 2020
Sponsor:
Information provided by (Responsible Party):
Imperial College London

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

Condition or disease Intervention/treatment Phase
Diabetes Device: GEKO device Other: Best Medical Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Electrical Stimulation in Diabetic Foot Ulceration
Actual Study Start Date : July 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: No device
Treated with best medical therapy
Other: Best Medical Therapy
Seen in outpatient clinic for wound care and ongoing advice

Experimental: 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.
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




Primary Outcome Measures :
  1. Number of Day Until 50% Healing of Leg Ulcer [ Time Frame: 8 weeks ]
    Time to 50% healing of leg ulcer, as measured by volume (3D camera)


Secondary Outcome Measures :
  1. Quality of Life (PAID, EQ5D, VAS, SF-12) [ Time Frame: 6 weeks ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02211495


Locations
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United Kingdom
Diabetic Foot Clinic, Praed Street, Paddington
London, United Kingdom, W2 1NY
Sponsors and Collaborators
Imperial College London
Investigators
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Principal Investigator: Kate Williams Imperial College London
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT02211495    
Other Study ID Numbers: 14/SC/0084
14HH1901 ( Other Identifier: Imperial College JRCO )
First Posted: August 7, 2014    Key Record Dates
Results First Posted: November 4, 2020
Last Update Posted: November 20, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
Diabetic Foot
Ulcer healing
Medical device to increase blood flow in foot
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases