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NCT04630795
ViscoTurf - Preventing Secondary Diabetic Foot Ulceration.
trial testing ViscoTurf insole in Diabetic Foot in 30 participants. Status unknown.
30 April 2024
Quick facts
| Lead sponsor | Staffordshire University |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 30 |
| Start date | 1 September 2023 |
| Primary completion | 30 April 2024 |
| Estimated completion | 30 December 2024 |
Drugs / interventions tested
- ViscoTurf insole
- Control insole
Conditions studied
- Diabetic Foot — all drugs for Diabetic Foot →
Sponsor
Staffordshire University
Who can join
18 and older, any sex, with Diabetic Foot. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04630795
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Related trials
Other recruiting trials for Diabetic Foot
Currently open trials in the same condition.
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- NCT06674980 — Clinical Trial Assessing Human Placental Membrane Products and Standard of Care Versus Standard of Care in Nonhealing DF · NA · recruiting
- NCT06760416 — Online Diabetic Foot Support Program- Care Kit · NA · active not recruiting
- NCT06552910 — Analyzing Anesthetic Techniques in Diabetic Foot Amputation · recruiting
- NCT06526936 — The Effect of Foot Care Training Given to Diabetic Hemodialysis Patients on Foot Care Behavior · NA · recruiting
Other Staffordshire University trials
Trials by the same sponsor.
- NCT04469374 — Menopause Osteoporosis and Bone Intervention Using Lifestyle Exercise. · NA · terminated
- NCT03089463 — Foot Assessment in People With Diabetes: A Quantitative Diagnostic Approach · suspended
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04630795 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Staffordshire University
- Last refreshed: 18 April 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04630795.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing