Status:
RECRUITING
Diabetic Foot Ulcer Research Study
Lead Sponsor:
Community Pharmacology Services Ltd
Collaborating Sponsors:
Keneric Healthcare
Conditions:
Diabetic Foot Ulcer
Diabetic Foot Ulcer Neuropathic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
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...
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.
Key Trial Info
Start Date :
April 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05762432
Start Date
April 26 2024
End Date
January 1 2027
Last Update
January 26 2026
Active Locations (2)
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1
NHS Lanarkshire
Airdrie, North Lanarkshire, United Kingdom, ML6 0JS
2
NHS Lothian
Livingston, West Lothian, United Kingdom, EH54 6PP