Actively Recruiting
Diabetic Foot Ulcer Research Study
Led by Community Pharmacology Services Ltd · Updated on 2026-01-26
100
Participants Needed
2
Research Sites
140 weeks
Total Duration
On this page
Sponsors
C
Community Pharmacology Services Ltd
Lead Sponsor
K
Keneric Healthcare
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Diabetic Foot Ulcer Research Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
NHS Lanarkshire
Airdrie, North Lanarkshire, United Kingdom, ML6 0JS
Actively Recruiting
2
NHS Lothian
Livingston, West Lothian, United Kingdom, EH54 6PP
Actively Recruiting
Research Team
D
Duncan Stang, MChS
CONTACT
K
Kaye McIntyre, MsC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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