ViscoTurf - Preventing Secondary Diabetic Foot Ulceration.

Staffordshire University

Status: Not yet enrolling

Conditions: Diabetic Foot

Treatments: Device: Control insole; Device: ViscoTurf insole

Study type: Observational

Funder types: Other

Identifiers

NCT04630795

SU-20-001

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 1 patient group

3D printed insole

Description:

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.

Treatment:

Device: ViscoTurf insole

Device: Control insole