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Evaluating Plantar Foot Pressure in a Novel Diabetic Offloading Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04336176
Recruitment Status : Completed
First Posted : April 7, 2020
Last Update Posted : April 7, 2020
Sponsor:
Collaborator:
The Leeds Teaching Hospitals NHS Trust
Information provided by (Responsible Party):
Anne-Maree Keenan, University of Leeds

Tracking Information
First Submitted Date  ICMJE March 26, 2020
First Posted Date  ICMJE April 7, 2020
Last Update Posted Date April 7, 2020
Actual Study Start Date  ICMJE March 22, 2018
Actual Primary Completion Date June 29, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 6, 2020)
Pressure Time Integral [ Time Frame: 1 day ]
Gait analysis
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2020)
Modified Monitoring Orthopaedic Shoes questionnaire [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluating Plantar Foot Pressure in a Novel Diabetic Offloading Device
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:
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
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE Diabetic Foot Ulcer
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • Active Comparator: PulseFlow DF boot
    PulseFlow DF boot
    Interventions:
    • Device: PulseFlow DF boot
    • Device: Usual standard of care
    • Device: Sham
  • Active Comparator: Usual Care
    Measurements will be taken from patients wearing usual standard of care
    Interventions:
    • Device: PulseFlow DF boot
    • Device: Usual standard of care
    • Device: Sham
  • Sham Comparator: Sham
    Sham shoe (closest to barefoot or baseline pressures)
    Interventions:
    • Device: PulseFlow DF boot
    • Device: Usual standard of care
    • Device: Sham
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 6, 2020)
12
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 29, 2018
Actual Primary Completion Date June 29, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 -
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04336176
Other Study ID Numbers  ICMJE 17/NS/0027
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Anne-Maree Keenan, University of Leeds
Study Sponsor  ICMJE University of Leeds
Collaborators  ICMJE The Leeds Teaching Hospitals NHS Trust
Investigators  ICMJE
Study Chair: Anne-Maree Keenan, PhD University of Leeds
PRS Account University of Leeds
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP