NCT04630795

ViscoTurf - Preventing Secondary Diabetic Foot Ulceration.

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.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Staffordshire University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2023-09-01
• Primary completion: 2024-04-30
• Completion: 2024-12-30
• First posted: 2020-11-16
• Last updated: 2023-04-18