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ViscoTurf - Preventing Secondary Diabetic Foot Ulceration.

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ClinicalTrials.gov Identifier: NCT04630795
Recruitment Status : Not yet recruiting
First Posted : November 16, 2020
Last Update Posted : November 16, 2020
Sponsor:
Collaborator:
King's College Hospital NHS Trust
Information provided by (Responsible Party):
Roozbeh Naemi, Staffordshire University

Brief Summary:

Diabetic Foot Ulceration (DFU) is one of the most common complication of diabetes costing the NHS over £970m annually. Management of foot ulcers is time-consuming and expensive with 45% taking more than six months to heal. Around 25% of patients re-ulcerate in 3 months, 40% within 1 year and 60% within 3 years and patients who have achieved wound closure are generally considered to be in remission rather than healed. A patient presenting with a foot ulcer has a greatly elevated risk of amputation while 80% of amputations can be prevented with the appropriate treatment, such as footwear intervention.

ViscoTurf is a novel, 3D printed, orthotic device designed specifically for this purpose. It emulates the function of natural turf to provide cushioning, optimised offloading and better microcirculation on the vulnerable areas of the plantar surface of the foot. This improves perfusion (the delivery of blood to the capillary bed) in the load bearing regions of the foot where the risk of re-ulceration is very high. An earlier feasibility study established proof-of-concept, showing ViscoTurf achieved a higher and longer-lasting increase in perfusion compared to conventional support structures. ViscoTurf insoles can be automatically designed to the foot size and 3D printed.

The main purpose of this study is to investigate the immediate effect of walking in Viscoturf insole (Turf-Like insoles) on skin perfusion and pressure at the sole of the foot in diabetic patients with history of ulceration. To achieve this, the immediate efficacy (effect as a result of walking for 15 meters) of Viscoturf insole will be assessed and compared to that of the standard flat insole. Intervention insole will be produced as 3D printed insole with the Turf-Like patches incorporated in the areas of interest, while the Standard Insole will be a standard 3D printed flat with NO Turf-like patches.


Condition or disease Intervention/treatment
Diabetic Foot Device: ViscoTurf insole Device: Control insole

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: An Investigation Into the Efficacy of a Patient-specific Turf-Like Insole in Reducing Plantar Pressure and Improving Skin Microcirculation in Patients With Diabetic Neuropathy.
Estimated Study Start Date : March 1, 2021
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
3D printed insole
Intervention insole will be produced as 3D printed insole with the Turf-Like patches incorporated in the areas of interest, while the Control Insole will be a standard 3D printed flat insole with NO Turf-like patches.
Device: ViscoTurf insole
Intervention insole will be produced as 3D printed insole with the Turf-Like patches incorporated in the areas of interest.
Other Name: Turf like insole

Device: Control insole
Control Insole will be a standard 3D printed flat insole with NO Turf-like patches.
Other Name: Standard insole




Primary Outcome Measures :
  1. Plantar skin perfusion before and after use. [ Time Frame: March-July 2021 ]
    The primary outcome measure is the improvement in plantar skin perfusion, which is the difference between skin perfusion before and after use.


Secondary Outcome Measures :
  1. Plantar Pressure during walking [ Time Frame: March-July2021 ]
    The secondary outcome measure is plantar pressure underneath the critical areas when walking in the insole.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population are selected from patients of King's diabetic foot clinic who meet the inclusion/exclusion criteria and who are consent to take part.
Criteria

Inclusion Criteria:

  • Type 1 OR Type 2 diabetes
  • Over 18
  • History of foot ulcer

Exclusion Criteria:

  • History of recent major lower limb surgery (amputation) or revascularisation and orthopaedic reconstruction over the last 3 months
  • Current active foot ulcer
  • Not be able to walk unassisted for 15 meters

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): NCT04630795


Contacts
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Contact: Roozbeh Naemi, PhD +441782295879 r.naemi@staffs.ac.uk

Sponsors and Collaborators
Staffordshire University
King's College Hospital NHS Trust
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Responsible Party: Roozbeh Naemi, Professor in Biomechanics, Staffordshire University
ClinicalTrials.gov Identifier: NCT04630795    
Other Study ID Numbers: SU-20-001
First Posted: November 16, 2020    Key Record Dates
Last Update Posted: November 16, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Participants with diabetes will be recruited from Kings College Hospital Trust (KCHT) using the inclusion and exclusion criteria previously outlined. A dedicated research podiatric practitioner nurse will first identify the patients who meet the inclusion exclusion criteria by searching through the KCHT diabetic foot patient database and clinical records.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Roozbeh Naemi, Staffordshire University:
Biomechanics, perfusion, plantar soft tissue, skin microcirculation,
Additional relevant MeSH terms:
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Diabetic Foot
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies