Diabetic Foot Ulcer Research Study
Recruiting now · Not applicable
Conditions studied: Diabetic Foot Ulcer, Diabetic Foot Ulcer Neuropathic, Diabetic Foot Ulcer Ischemic
In brief
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.
Key facts
- Study ID
- NCT05762432
- Run by
- Community Pharmacology Services Ltd
- People needed
- 100
- Starts
- 2024-04-26
- Expected to finish
- 2027-01-01
- Last updated by the study team
- 2026-01-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 may not qualify if…
- 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.
Where it is running
- NHS Lanarkshire — Airdrie, North Lanarkshire, United Kingdom (enrolling)
- NHS Lothian — Livingston, West Lothian, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
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