NCT04336176

Evaluating Plantar Foot Pressure in a Novel Diabetic Offloading Device

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of Leeds · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
DEVICE	PulseFlow DF boot	Offloading boot
DEVICE	Usual standard of care	Usual standard of care (offloading device)
DEVICE	Sham	Sham shoe (closest to barefoot or baseline pressures)

Timeline

• Start date: 2018-03-22
• Primary completion: 2018-06-29
• Completion: 2018-07-29
• First posted: 2020-04-07
• Last updated: 2020-04-07

Locations

1 site across 1 country: United Kingdom