Status:
COMPLETED
Evaluating Plantar Foot Pressure in a Novel Diabetic Offloading Device
Lead Sponsor:
University of Leeds
Collaborating Sponsors:
The Leeds Teaching Hospitals NHS Trust
Conditions:
Diabetic Foot Ulcer
Eligibility:
All Genders
Phase:
NA
Brief Summary
The impacts from diabetes are both patient related and healthcare based. Offloading is recognised as the priority treatment for healing neuropathic and neuro-ischaemic plantar foot ulcers. The new Pul...
Detailed Description
The impacts from diabetes are both patient related and healthcare based. DFU is associated with a high mortality rate at 34% at 1 year. There is an associated higher limb amputation rate from DFU than...
Eligibility Criteria
Inclusion
- Plantar forefoot diabetic foot ulcer over the 1st, 2nd, 3rd, 4th or 5th MTP joints
- Neuropathic or Neuro-Ischaemic classification foot ulcer (taken from the TEXAS classification system)
- Orthotic intervention for offloading/usual standard
- English speaking and reading
- Palpable foot pulses and/or Ankle Brachial Pressure Indices of values 0.8 to 1.29.
Exclusion
- Being treated for or having an active Charcot Arthropathy
- Ankle Brachial Pressure Indices of \<0.8 and \>1.29. Using a standardised reproducible instrument called the Huntleigh Dopplex Ability Unit (DA100PB).
- Purely ischaemic classification foot ulcer
- Clinically active Infection causing lower leg swelling
- Current active osteomyelitis
- Due to alterations in gait, patients with diagnosed vascular dementia, Parkinson's, alcoholism or other major medically related gait alterations i.e. intoxication, brain cancers, muscular degeneration diseases, inflammatory arthritis, etc. This does not include osteo-arthritis.
- Fractures of the foot
- Pregnancy
- Patients with forefoot trans metatarsal or major amputations
- Temporary, accommodating or footwear not designed to offload used as their USC
- Under another trial regarding foot dressings or off loading -
Key Trial Info
Start Date :
March 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 29 2018
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04336176
Start Date
March 22 2018
End Date
July 29 2018
Last Update
April 7 2020
Active Locations (1)
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1
The Leeds Teaching Hospitals NHS Trust.
Leeds, United Kingdom