Comparing a new wound dressing for diabetic foot ulcers to standard care

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Pulsating electromagnetic field therapy for diabetic foot ulcers

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  Recruiting National Defence University of Malaysia · Kuala Lumpur · NCT07465640

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.