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ViscoTurf - Preventing Secondary Diabetic Foot Ulceration.

NCT04630795 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2023-04-18

No results posted yet for this study

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.

Conditions

  • Diabetic Foot

Interventions

DEVICE

ViscoTurf insole

Intervention insole will be produced as 3D printed insole with the Turf-Like patches incorporated in the areas of interest.

DEVICE

Control insole

Control Insole will be a standard 3D printed flat insole with NO Turf-like patches.

Sponsors & Collaborators

  • King's College Hospital NHS Trust

    collaborator OTHER

  • Staffordshire University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2024-04-30
Completion
2024-12-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04630795 on ClinicalTrials.gov