What is the RTD Wound Dressing studying for diabetic foot ulcers?

The RTD Wound Dressing is being studied to compare its safety and healing performance against the usual NHS standard dressing for diabetic foot ulcers. Researchers want to learn if it can improve wound healing and reduce wound size. The study is sponsored by Community Pharmacology Services Ltd and conducted in NHS podiatry clinics.

Who may be eligible for this diabetic foot ulcer clinical trial?

Adults 18 years or older with type 1 or type 2 diabetes and a non-infected neuropathic, ischaemic, or neuro-ischaemic foot ulcer may be eligible. Participants must understand English and be able to consent. Certain allergies and pregnancy exclude participation. Please review eligibility criteria for more details.

Is there any cost to participate in this diabetic foot ulcer clinical trial?

Study-related care, including the wound dressing and all trial visits, is provided at no cost. However, personal travel expenses to the clinic may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID05762432

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

Led by Community Pharmacology Services Ltd · Updated on 2026-01-26

100

Participants Needed

Research Sites

4 weeks

Total Duration

AI-Summary

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.

CONDITIONS

Brief Title

Diabetic Foot Ulcer Research Study

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Male or female aged 18 years or older with type 1 or type 2 diabetes
New treatment for a neuropathic, ischaemic, or neuro-ischaemic non-infected diabetic foot ulcer
Able to understand and follow verbal and written instructions in English
Have full mental capacity and able to give written informed consent including for medical photography
Diabetic foot ulcer size greater than 10 mm² and less than 100 mm²

You will not qualify if you...

Known allergy or hypersensitivity to any ingredient in the Keneric healthcare RTD Wound Dressing
Unable to follow the study protocol or use the offloading system daily as standard of care
Suspected malignancy in the wound
Critical limb ischaemia
Pregnant or breastfeeding female
Women of childbearing potential not using medically accepted contraception when sexually active

Research Team

Duncan Stang, MChS

Kaye McIntyre, MsC

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