Diabetic Foot Ulcer Research Study
Diabetic Foot Ulcer, Diabetic Foot Ulcer Neuropathic, Diabetic Foot Ulcer Ischemic
About this trial
This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring Diabetes, Foot Ulcer, Diabetic Foot Ulcer
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Study Device
Standard of Care
This Arm of the study will receive the study device. Although the Study Device is not experimental as it is already CE marked and being used for it's intended purpose.
This arm of the study will use the NHS' existing standard of care device as is normally used in podiatry clinics.