Diabetic Foot Ulcer Research Study

Not Applicable

Recruiting

• Conditions: Diabetic Foot Ulcer; Diabetic Foot Ulcer Neuropathic; Diabetic Foot Ulcer Ischemic

• Registration Number: NCT05762432
• Lead Sponsor: Community Pharmacology Services Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-2-17
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - Male or female, aged =18 years old with a diagnosis of type 1 or type 2 diabetes.<br><br> - New presentation for treatment of a neuropathic, ischaemic or neuro- ischaemic non-<br> infected DFU<br><br> - Subjects must be able to follow verbal and written instructions in English<br><br> - Subjects must have full mental capacity and able to give written informed consent to<br> participation in the trial including medical photography for the purposes of the<br> clinical trial or clinical care.<br><br> - DFU is >10mm2 and <100mm2<br><br>Exclusion Criteria:<br><br> - Known allergy/hypersensitivity to any ingredient contained in the Keneric healthcare<br> RTD Wound Dressing<br><br> - Participants who will have problems following the protocol, including the offloading<br> system, provided as standard of care, to wear on a daily basis<br><br> - Suspected malignancy in the wound<br><br> - Critical limb ischaemia<br><br> - Pregnant or breastfeeding females<br><br> - Women of childbearing potential and not using a medically accepted form of<br> contraception when sexually active.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Completion of Wound Healing;Reduction in Wound Area

Secondary Outcome Measures

Name	Time	Method
Wound Infection Rates;Dressing Changes