Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02211495 |
| Other study ID # |
14/SC/0084 |
| Secondary ID |
14HH1901 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 2014 |
| Est. completion date |
December 2015 |
Study information
| Verified date |
November 2020 |
| Source |
Imperial College London |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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
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.
