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

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.

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.

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.