Comparing a new wound dressing for diabetic foot ulcers to standard care
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
This study is testing a new wound dressing for diabetic foot ulcers to see if it works better than the usual treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Community Pharmacology Services Ltd Academic / other |
| Locations | 2 sites (Airdrie, North Lanarkshire and 1 other locations) |
| Trial ID | NCT05762432 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and effectiveness of the RTD Wound Dressing in treating non-infected neuropathic, ischaemic, and neuro-ischaemic diabetic foot ulcers compared to the current standard of care. Participants will be assigned to either the study device or the standard dressing during their regular NHS podiatry clinic visits. The primary outcomes include complete wound healing at 12 weeks and the percentage reduction in wound area at the same time point. The study will be conducted in three diabetic foot clinics within NHS Lanarkshire under an open-label, comparative design.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with type 1 or type 2 diabetes who have a new presentation of a non-infected diabetic foot ulcer.
Not a fit: Patients with known allergies to the study dressing, critical limb ischaemia, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for diabetic foot ulcers, potentially leading to faster healing and improved patient outcomes.
How similar studies have performed: While this approach is comparative, similar studies evaluating advanced wound dressings have shown promising results in improving healing outcomes for diabetic foot ulcers.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female, aged ≥18 years old with a diagnosis of type 1 or type 2 diabetes. * New presentation for treatment of a neuropathic, ischaemic or neuro- ischaemic non- infected DFU * Subjects must be able to follow verbal and written instructions in English * Subjects must have full mental capacity and able to give written informed consent to participation in the trial including medical photography for the purposes of the clinical trial or clinical care. * DFU is \>10mm2 and \<100mm2 Exclusion Criteria: * Known allergy/hypersensitivity to any ingredient contained in the Keneric healthcare RTD Wound Dressing * Participants who will have problems following the protocol, including the offloading system, provided as standard of care, to wear on a daily basis * Suspected malignancy in the wound * Critical limb ischaemia * Pregnant or breastfeeding females * Women of childbearing potential and not using a medically accepted form of contraception when sexually active.
Where this trial is running
Airdrie, North Lanarkshire and 1 other locations
- NHS Lanarkshire — Airdrie, North Lanarkshire, United Kingdom (Recruiting)
- NHS Lothian — Livingston, West Lothian, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Kaye McIntyre, MsC — NHS Lanarkshire
- Study coordinator: Duncan Stang, MChS
- Email: duncan.stang@lanarkshire.scot.nhs.uk
- Phone: 07554333493
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.