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

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Device: PulseFlow DF boot; Device: Usual standard of care; Device: Sham

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Leeds, United Kingdom
    • The Leeds Teaching Hospitals NHS Trust.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PulseFlow DF boot	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)
Active Comparator: Usual Care; Measurements will be taken from patients wearing usual standard of care	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)
Sham Comparator: Sham; Sham shoe (closest to barefoot or baseline pressures)	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pressure Time Integral	Gait analysis	1 day

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Leeds
• Collaborators: The Leeds Teaching Hospitals NHS Trust
• Investigators: Study Chair: Anne-Maree Keenan, PhD, University of Leeds

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2018
• Primary Completion (Actual): June 29, 2018
• Study Completion (Actual): July 29, 2018

Study Registration Dates

• First Submitted: March 26, 2020
• First Submitted That Met QC Criteria: April 6, 2020
• First Posted (Actual): April 7, 2020

Study Record Updates

• Last Update Posted (Actual): April 7, 2020
• Last Update Submitted That Met QC Criteria: April 6, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer
• Other Study ID Numbers: 17/NS/0027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No