Clinical trial NCT04336176: Evaluating Plantar Foot Pressure in a Novel Diabetic Offloading Device
Official title: Does a Novel Diabetic Foot Offloading Boot Reduce the Pressure Time Integral Compared to Usual Standard Care, in Patients With Diabetic Foot Ulcer? A Proof of Concept Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot Ulcer
Lead sponsor: University of Leeds
Sponsor class: OTHER
Collaborators: name: The Leeds Teaching Hospitals NHS Trust
First posted: 2020-04-07
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Proof of concept study comparing the ability to redistribute forefoot pressure using a new foot offloading device compared to usual standard care. The sample will be purposively selected taken from a local population of active diabetic foot ulcer patients. The measurements will be taken from patients wearing usual standard of care, sham shoe (closest to barefoot or baseline pressures) and the PulseFlow DF boot. The measurements from each patient will be collated to compute pti averages for the comparison
Primary purpose: DEVICE_FEASIBILITY

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 PulseFlow DF boot is a device which claims to off load but has little or no evidence on diabetic foot ulcer (DFU) subjects. Thus the primary aim of this study is to observe forefoot plantar pressures in a cross sectional purposively selected sample compared to usual standard of care.

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 other causes. The high mortality rate, high amputation rate and increased socio-economic burden means providing high quality evidence based DFU service provision should be a NHS priority. Offloading is recognised as the priority treatment for healing neuropathic and neuro-ischaemic plantar foot ulcers. Since the provision of non removable devices or total contact casts (TCC) is poor, options have to be available that are equivalent in effectiveness at off loading and healing DFU. By improving the quality of offloading choices and acceptability for devices this will improve healing rates and reduce the cost burden where currently in the UK diabetic foot care in 2015 accounted for 0.6%/585.5million pounds of the NHS budget. The evidence for effectiveness of non removable devices is poor. Therefore any device that offloads to the equivalent or more than previous devices and current usual standard of care must be evidenced. The new PulseFlow DF boot is such a device which claims to off load but has little or no evidence on DFU subjects. Thus the primary aim of this study is to observe forefoot plantar pressures in a cross sectional purposively selected sample compared to usual standard of care.

Eligibility criteria: Inclusion Criteria:

1. Plantar forefoot diabetic foot ulcer over the 1st, 2nd, 3rd, 4th or 5th MTP joints
2. Neuropathic or Neuro-Ischaemic classification foot ulcer (taken from the TEXAS classification system)
3. Orthotic intervention for offloading/usual standard
4. English speaking and reading
5. Palpable foot pulses and/or Ankle Brachial Pressure Indices of values 0.8 to 1.29.

Exclusion Criteria:

1. Being treated for or having an active Charcot Arthropathy
2. Ankle Brachial Pressure Indices of \<0.8 and \>1.29. Using a standardised reproducible instrument called the Huntleigh Dopplex Ability Unit (DA100PB).
3. Purely ischaemic classification foot ulcer
4. Clinically active Infection causing lower leg swelling
5. Current active osteomyelitis
6. 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.
7. Fractures of the foot
8. Pregnancy
9. Patients with forefoot trans metatarsal or major amputations
10. Temporary, accommodating or footwear not designed to offload used as their USC
11. Under another trial regarding foot dressings or off loading -

Primary outcomes:
measure: Pressure Time Integral
timeFrame: 1 day
Secondary outcomes:
measure: Modified Monitoring Orthopaedic Shoes questionnaire
timeFrame: 1 day (post gait analaysis)
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: The Leeds Teaching Hospitals NHS Trust.
Study officials:
affiliation: University of Leeds
name: Anne-Maree Keenan, PhD
role: STUDY_CHAIR
References: