Background: Venous leg ulcers (VLUs) are nonhealing wounds that pose considerable clinical and economic challenges.

Healing outcomes with existing standard-of-care (SOC) remain limited, creating a pressing need for more effective therapeutic options

Methods: An interim analysis of this randomized controlled multicenter clinical trial evaluated intact fish skin graft (IFSG) and SOC versus SOC alone in nonhealing VLUs. The primary end-point was the percentage of target ulcers achieving complete wound closure in 12 weeks, defined as 100% re-epithelialization without drainage for two consecutive weeks,

confirmed by blinded independent review.

Background: Venous leg ulcers (VLUs) impose substantial morbidity and Medicare spending, yet many real-world ulcers

remain refractory to standard of care (SOC). Intact fish-skin graft (IFSG) is a biologic graft used for chronic (hard-to-heal)

wounds. We evaluated the comparative effectiveness of IFSG versus SOC in routine practice using a specialty wound registry

with real world evidence design features intended to minimize bias.

Background: Venous leg ulcers (VLUs) are nonhealing wounds that pose considerable clinical and economic challenges.

Healing outcomes with existing standard-of-care (SOC) remain limited, creating a pressing need for more effective therapeutic options.

Background: Venous leg ulcers (VLUs) impose substantial morbidity and Medicare spending, yet many real-world ulcers remain refractory to standard of care (SOC). Intact fish-skin graft (IFSG) is a biologic graft used for chronic (hard-to-heal) wounds. We evaluated the comparative effectiveness of IFSG versus SOC in routine practice using a specialty wound registry with real world evidence design features intended to minimize bias.