ViscoTurf - Preventing Secondary Diabetic Foot Ulceration.

Not yet recruiting

• Conditions: Diabetic Foot
• Interventions: Device: ViscoTurf insole; Device: Control insole

• Registration Number: NCT04630795
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-13
• Study First Submitted QC: 2020-11-13
• Study First Posted: 2020-11-16
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-17
• Last Update Posted: 2023-04-18
• Study Start: 2023-09-01
• Primary Completion: 2024-04-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
3D printed insole	Control 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.
3D printed insole	ViscoTurf 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.

Primary Outcome Measures

Name	Time	Method
Plantar skin perfusion before and after use.	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

Name	Time	Method
Plantar Pressure during walking	March-July2021	The secondary outcome measure is plantar pressure underneath the critical areas when walking in the insole.