NCT02334241

The Sorbact® Antimicrobial Dressing in the Holistic Wound Management Of Diabetic Foot ulCers (Phase III Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: INRESA Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Foot Ulcer, Diabetic

Interventions

Type	Name	Description
DEVICE	Sorbact®	Sorbact® is available in many types and sizes. These different presentations are available allowing management of quite all types of wounds of various anatomical locations, sizes or depths. Application of any of these presentations is allowed and may change during study course according to wound evolution.
DEVICE	Best local cares	Participating centers will provide a list of dressings they planned to use in the best local cares arm. This list must be validated by the study Steering Committee members

Timeline

• Start date: 2014-10-01
• Primary completion: 2016-09-01
• Completion: 2017-04-01
• First posted: 2015-01-08
• Last updated: 2017-08-31

Locations

15 sites across 3 countries: Czechia, France, Poland