Evaluating Plantar Foot Pressure in a Novel Diabetic Offloading Device

Not Applicable

Completed

• Conditions: Diabetic Foot Ulcer
• Interventions: Device: PulseFlow DF boot; Device: Usual standard of care; Device: Sham

• Registration Number: NCT04336176
• Lead Sponsor: University of Leeds

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.

Study Timeline

• Study Start: 2018-03-22
• Primary Completion: 2018-06-29
• Study Completion: 2018-07-29
• Study First Submitted: 2020-03-26
• Status Verified: 2020-04
• Study First Submitted QC: 2020-04-06
• Last Update Submitted: 2020-04-06
• Study First Posted: 2020-04-07
• Last Update Posted: 2020-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sham	Sham	Sham shoe (closest to barefoot or baseline pressures)
PulseFlow DF boot	PulseFlow DF boot	PulseFlow DF boot
PulseFlow DF boot	Usual standard of care	PulseFlow DF boot
PulseFlow DF boot	Sham	PulseFlow DF boot
Usual Care	PulseFlow DF boot	Measurements will be taken from patients wearing usual standard of care
Usual Care	Usual standard of care	Measurements will be taken from patients wearing usual standard of care
Usual Care	Sham	Measurements will be taken from patients wearing usual standard of care
Sham	PulseFlow DF boot	Sham shoe (closest to barefoot or baseline pressures)
Sham	Usual standard of care	Sham shoe (closest to barefoot or baseline pressures)

Primary Outcome Measures

Name	Time	Method
Pressure Time Integral	1 day	Gait analysis

Secondary Outcome Measures

Name	Time	Method
Modified Monitoring Orthopaedic Shoes questionnaire	1 day (post gait analaysis)	Multiple choice questionnaire and visual analogue pain scale measuring relevant factors of use and usability of orthopaedic shoes from a patient's perspective.

Trial Locations

Locations (1)

The Leeds Teaching Hospitals NHS Trust.; 🇬🇧 Leeds, United Kingdom