Diabetic Foot Ulcer Research Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCommunity Pharmacology Services Ltd
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Wound Dressing
- NHS Standard Dressing
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Community Pharmacology Services Ltd
Lead sponsor
Keneric Healthcare
Collaborator
Source ClinicalTrials.gov