Diabetic Foot Ulcer Research Study

Launched by COMMUNITY PHARMACOLOGY SERVICES LTD · Feb 28, 2023

Keywords

ClinConnect Summary

The Diabetic Foot Ulcer Research Study is looking to see how safe and effective a new wound dressing device is compared to the usual treatment available through the NHS for diabetic foot ulcers. The main goals of the study are to find out if the new device can help heal wounds completely within 12 weeks and to measure how much the wound size decreases in that time.

To participate in the trial, you need to be at least 18 years old and have diabetes, either type 1 or type 2. You should have a new diabetic foot ulcer that is not infected and falls within a specific size range. If you join the study, you will continue your regular appointments at your NHS podiatry clinic and will be randomly assigned to receive either the new device or the standard treatment. Participants should be able to understand instructions in English and provide consent for the study. This trial is currently recruiting, and it’s important to know that certain conditions, like pregnancy or specific health issues, may prevent someone from participating.

Gender

ALL

Eligibility 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.