ViscoTurf - Preventing Secondary Diabetic Foot Ulceration.

NCT04630795 | Unknown

• 1 other identifier: SU-20-001
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetic Foot

Keywords

Biomechanics, perfusion, plantar soft tissue, skin microcirculation,

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Plantar Pressure during walking

  March-July2021

Study Arms (1)

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; Device: Control insole

Interventions

ViscoTurf insole DEVICE

Intervention insole will be produced as 3D printed insole with the Turf-Like patches incorporated in the areas of interest.

Also known as: Turf like insole

3D printed insole

Control insole DEVICE

Control Insole will be a standard 3D printed flat insole with NO Turf-like patches.

Also known as: Standard insole

3D printed insole

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Type 1 OR Type 2 diabetes
• Over 18
• History of foot ulcer

You may not qualify if:

• 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

Sponsors & Collaborators

• Staffordshire University: lead
• King's College Hospital NHS Trust: collaborator

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Central Study Contacts

Roozbeh Naemi, PhD

CONTACT

+441782295879; r.naemi@staffs.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Biomechanics

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: November 16, 2020
• Study Start: September 1, 2023
• Primary Completion: April 30, 2024
• Study Completion: December 30, 2024
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share