Foot Ulcer, Diabetic Clinical Trial
Official title:
The Sorbact® Antimicrobial Dressing in the Holistic Wound Management Of Diabetic Foot ulCers (Phase III Study)
The aim of this study is to demonstrate, during a 12-week follow-up, a greater efficacy of using Sorbact® dressing technology in addition to best local cares compared to best local cares alone in the management of diabetic foot ulcers
This study will select a target population of diabetic patients treated for foot ulcers of
neuropathic origin, with or without arterial disease but not presenting critical limb
ischaemia. No definitive wound infection should be present at inclusion. According to
randomization, all present ulcers at baseline will be treated either with best local cares
not including Sorbact® dressing or including systematically for all ulcers this medical
device.
The main study endpoint will be a composite criterion defining a favourable limb outcome for
a given patient. This criterion will be considered as present if total open wound area has
decreased by 50% or more at last available evaluation whereas no definitive infection has
occurred and no amputation has been required.
Patients will be followed over a maximal period of 12 weeks. At D0 (inclusion), W2, W4, W6,
W8, W10 and W12 a detailed description of ulcer aspect will be done. Applied dressing will be
removed according to a standardized procedure. Wound area tracing and photography of all
ulcers will be performed. Off-loading system's adherence will be checked.
Between these weekly evaluations, all performed local cares will be reported and each
dressing removal will be performed by using a similar procedure.
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