Evaluating Plantar Foot Pressure in a Novel Diabetic Offloading Device

NCT04336176 | Completed

• 1 other identifier: 17/NS/0027
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• Pressure Time Integral

  Gait analysis

  1 day

Secondary Outcomes (1)

• Modified Monitoring Orthopaedic Shoes questionnaire

  1 day (post gait analaysis)

Study Arms (3)

PulseFlow DF boot

ACTIVE COMPARATOR

PulseFlow DF boot

Device: PulseFlow DF boot; Device: Usual standard of care; Device: Sham

Usual Care

ACTIVE COMPARATOR

Measurements will be taken from patients wearing usual standard of care

Device: PulseFlow DF boot; Device: Usual standard of care; Device: Sham

Sham

SHAM COMPARATOR

Sham shoe (closest to barefoot or baseline pressures)

Device: PulseFlow DF boot; Device: Usual standard of care; Device: Sham

Interventions

PulseFlow DF boot DEVICE

Offloading boot

PulseFlow DF boot; Sham; Usual Care

Usual standard of care DEVICE

Usual standard of care (offloading device)

PulseFlow DF boot; Sham; Usual Care

Sham DEVICE

Sham shoe (closest to barefoot or baseline pressures)

PulseFlow DF boot; Sham; Usual Care

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 -

Sponsors & Collaborators

• University of Leeds: lead
• The Leeds Teaching Hospitals NHS Trust: collaborator

Study Sites (1)

The Leeds Teaching Hospitals NHS Trust.

Leeds, United Kingdom

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Anne-Maree Keenan, PhD

  University of Leeds

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of Applied Health Research

Model Details: 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

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: April 7, 2020
• Study Start: March 22, 2018
• Primary Completion: June 29, 2018
• Study Completion: July 29, 2018
• Last Updated: April 7, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)