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Evaluating Plantar Foot Pressure in a Novel Diabetic Offloading Device

NCT04336176 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2020-04-07

No results posted yet for this study

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.

Conditions

  • Diabetic Foot Ulcer

Interventions

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)

Sponsors & Collaborators

  • The Leeds Teaching Hospitals NHS Trust

    collaborator OTHER

  • University of Leeds

    lead OTHER

Principal Investigators

  • Anne-Maree Keenan, PhD · University of Leeds

Study Design

Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-22
Primary Completion
2018-06-29
Completion
2018-07-29

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04336176 on ClinicalTrials.gov