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MediWound Announces New EscharEx® Phase II Data Demonstrating Strong Link Between Wound Bed Preparation and Wound Closure in Venous Leg Ulcers
Globenewswire· 2025-08-13 12:45
Core Insights - MediWound Ltd. announced the publication of a post hoc analysis demonstrating a strong correlation between wound bed preparation (WBP) and wound closure in patients with chronic venous leg ulcers (VLUs) [1][4] Group 1: Study Details - The analysis included data from 119 chronic VLU patients randomized in a 3:3:2 ratio to receive treatments with either EscharEx, a placebo gel, or non-surgical standard care, followed by weekly dressings for 12 weeks [2] - WBP was defined as the complete removal of nonviable tissue and full coverage of the wound bed with healthy granulation tissue [2] Group 2: Key Findings - Wounds that failed to achieve WBP had a 90% probability of not healing, indicating a high negative predictive value [7] - Wounds that achieved WBP were 4.1 times more likely to close compared to those that did not, with a statistical significance of p = 0.0004 [7] - Early achievement of WBP (within 14 days) significantly increased the likelihood of healing, with a relative risk of 2.4 (p = 0.0005) [7] - Wounds that did not reach WBP had a 12-fold higher risk of remaining unhealed throughout the study period (hazard ratio = 12, p < 0.0001) [7] Group 3: Implications for Therapy - The findings reinforce the clinical importance of complete debridement and timely full granulation tissue coverage in facilitating wound closure [4] - EscharEx has demonstrated therapeutic potential to improve healing outcomes by accelerating wound bed preparation in patients with venous leg ulcers [4][5] Group 4: About EscharEx - EscharEx is a bromelain-based, bioactive enzymatic therapy in advanced clinical development for the debridement of chronic and hard-to-heal wounds, showing a favorable safety profile and effective wound bed preparation [6] - A global Phase III study in venous leg ulcers is currently underway, with a clinical study in diabetic foot ulcers in preparation [6]