Pilot Study to Compare the Safety and Effectiveness of RTD Wound Dressing Versus Standard NHS Care in Treating Diabetic Foot Ulcers

What this Trial Is About

Researchers are evaluating the safety and performance of the RTD Wound Dressing compared to the current standard care device used by the NHS for treating non-infected neuropathic, ischaemic, and neuro-ischaemic diabetic foot ulcers. This clinical evaluation is conducted in an open-label, randomized design within NHS Lanarkshires diabetic foot clinics. The primary goals are to assess complete wound healing and reduction in wound area after 12 weeks. Participants will be randomly assigned to either receive the RTD Wound Dressing, which is already CE marked and used for its intended purpose, or the NHS standard dressing normally used in podiatry clinics. Both groups will continue their regular NHS podiatry appointments. The study compares outcomes between these two groups over the 12-week period. During the study, participants will attend routine clinic visits where wound healing progress, wound area reduction, infection rates, and dressing changes will be monitored. Researchers will use medical photography and other evaluations to track healing and safety. Participants must be able to follow instructions and provide informed consent. The total follow-up period is 12 weeks with assessments focused on wound healing and related outcomes.

Diabetic Foot Ulcer Research Study