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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetic Foot
• Intervention / Treatment: Device: ViscoTurf insole; Device: Control insole

• Study Type: Observational
• Enrollment (Anticipated): 30

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population are selected from patients of King's diabetic foot clinic who meet the inclusion/exclusion criteria and who are consent to take part.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
3D printed 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.	Device: ViscoTurf insole; Intervention insole will be produced as 3D printed insole with the Turf-Like patches incorporated in the areas of interest.; Other Names: Turf like insole; Device: Control insole; Control Insole will be a standard 3D printed flat insole with NO Turf-like patches.; Other Names: Standard insole

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Staffordshire University
• Collaborators: King's College Hospital NHS Trust

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2023
• Primary Completion (Anticipated): April 30, 2024
• Study Completion (Anticipated): December 30, 2024

Study Registration Dates

• First Submitted: November 13, 2020
• First Submitted That Met QC Criteria: November 13, 2020
• First Posted (Actual): November 16, 2020

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 17, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Biomechanics, perfusion, plantar soft tissue, skin microcirculation,
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Ulcer; Diabetic Foot
• Other Study ID Numbers: SU-20-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Participants with diabetes will be recruited from Kings College Hospital Trust (KCHT) using the inclusion and exclusion criteria previously outlined. A dedicated research podiatric practitioner nurse will first identify the patients who meet the inclusion exclusion criteria by searching through the KCHT diabetic foot patient database and clinical records.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No