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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

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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Device: PulseFlow DF boot Device: Usual standard of care Device: Sham Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
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
Official Title: 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
Actual Study Start Date : March 22, 2018
Actual Primary Completion Date : June 29, 2018
Actual Study Completion Date : July 29, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: PulseFlow DF boot
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)




Primary Outcome Measures :
  1. Pressure Time Integral [ Time Frame: 1 day ]
    Gait analysis


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04336176


Locations
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United Kingdom
The Leeds Teaching Hospitals NHS Trust.
Leeds, United Kingdom
Sponsors and Collaborators
University of Leeds
The Leeds Teaching Hospitals NHS Trust
Investigators
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Study Chair: Anne-Maree Keenan, PhD University of Leeds
  Study Documents (Full-Text)

Documents provided by Anne-Maree Keenan, University of Leeds:
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Responsible Party: Anne-Maree Keenan, Chair of Applied Health Research, University of Leeds
ClinicalTrials.gov Identifier: NCT04336176    
Other Study ID Numbers: 17/NS/0027
First Posted: April 7, 2020    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Foot Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies