NCT05762432

Diabetic Foot Ulcer Research Study

A Pilot Open Label Prospective, Randomised, Study to Evaluate the Safety and Efficacy of Keneric Healthcare RTD Wound Dressing in the Treatment of Diabetic Foot Ulcers Compared to Standard of Care

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Community Pharmacology Services Ltd · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to compare safety and performance of the study device to the current typical NHS standards of care device. The main outcomes it aims to achieve are: Complete wound healing at 12 weeks (100% epithelialised) % Reduction in wound area at 12 weeks Participants will attend their NHS podiatry clinic appointment as normal and will be assigned either the study device or the current typical NHS standard of care device. Researchers will compare the study device group to the standard group to assess the outcomes mentioned previously.

Detailed description

The purpose of this clinical trial is to evaluate the safety and performance of the RTD Wound Dressing in the treatment of non-infected neuropathic, ischaemic, and neuro-ischaemic diabetic foot ulcers versus standard of care. This clinical evaluation study will be performed under an open-label, comparative, design in the single health board of NHS Lanarkshire within 3 diabetic foot clinics.

Conditions

• Diabetic Foot Ulcer
• Diabetic Foot Ulcer Neuropathic
• Diabetic Foot Ulcer Ischemic

Interventions

Type	Name	Description
DEVICE	Wound Dressing	RTD Wound Dressing that is being investigated
DEVICE	NHS Standard Dressing	This is the standard dressing used by NHS staff when currently dealing with a diabetic foot ulcer

Timeline

• Start date: 2024-04-26
• Primary completion: 2026-12-01
• Completion: 2027-01-01
• First posted: 2023-03-09
• Last updated: 2026-01-26

Locations

2 sites across 1 country: United Kingdom

Regulatory

• FDA-regulated device study