MediWound Releases New Phase II Data For EscharEx® Showing Strong Correlation Between Wound Bed Preparation & Wound Closure In Venous Leg Ulcers

MediWound Ltd., a global leader in next-generation enzymatic therapeutics for tissue repair, has announced the publication of a study titled “The Correlation Between Wound Bed Preparation and Wound Closure in Venous Leg Ulcers: A Post Hoc Analysis of the ChronEx Multicenter Randomized Controlled Trial” in Advances in Wound Care, a leading peer-reviewed journal focused on tissue injury and repair. The study presents data demonstrating a strong relationship between wound bed preparation (WBP) and wound closure in patients with chronic venous leg ulcers (VLUs).

The analysis included data from 119 chronic VLU patients who were randomized in a 3:3:2 ratio to receive up to two weeks of daily treatment with either EscharEx, a placebo gel vehicle, or non-surgical standard care, followed by standard dressings applied weekly for 12 weeks. Researchers compared the incidence of wound closure between patients who achieved WBP by day 14 and those who did not, as well as between those who achieved WBP at any time during the study and those who never reached it. WBP was defined as the complete removal of nonviable tissue and full coverage of the wound bed with healthy granulation tissue.

Dr. Marissa J. Carter, a clinical trial specialist and biostatistician focused on chronic wound care research, mentioned, “While wound bed preparation has long been accepted as the conceptual foundation for managing chronic wounds, this landmark analysis provides evidence, for the first time, that there is a strong correlation between the two. Importantly, the findings indicate a high negative predictive value associated with the lack of wound bed preparation. In other words, wounds that are not adequately prepared are highly unlikely to proceed to closure, underscoring the essential role of wound bed preparation in the healing process. Without adequate wound bed preparation, chronic wounds rarely heal.”

The findings revealed that wounds failing to achieve WBP had a 90% probability of not healing. Wounds that reached WBP were 4.1 times more likely to close compared to those that did not, and early achievement of WBP within 14 days was associated with a 2.4-fold increased likelihood of healing. Additionally, wounds that did not reach WBP had a 12-fold higher risk of remaining unhealed throughout the study period. 

These results highlight the clinical importance of thorough debridement and timely coverage of the wound bed with healthy tissue to facilitate wound closure. The data also support the therapeutic potential of EscharEx in accelerating wound bed preparation and improving healing outcomes in patients with venous leg ulcers.