ViscoTurf - Preventing Secondary Diabetic Foot Ulceration.

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Diabetic Foot

Intervention / Treatment
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* Device: ViscoTurf insole
* Device: Control insole


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 3D printed insole<br>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<br>* Intervention insole will be produced as 3D printed insole with the Turf-Like patches incorporated in the areas of interest.<br>* Other names: Turf like insole;Device: Control insole<br>* Control Insole will be a standard 3D printed flat insole with NO Turf-like patches.<br>* Other names: Standard insole;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plantar skin perfusion before and after use. | The primary outcome measure is the improvement in plantar skin perfusion, which is the difference between skin perfusion before and after use. | March-July 2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plantar Pressure during walking | The secondary outcome measure is plantar pressure underneath the critical areas when walking in the insole. | March-July2021 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biomechanics, perfusion, plantar soft tissue, skin microcirculation,