Evaluation of Intact Fish Skin Grafts Plus Standard Care in the Treatment of Venous Leg Ulcers: an interim analysis of the THOR trial

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 endpoint 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.

Results

The statistical analysis revealed that the treatment arm improved full wound closure at 12 weeks over SOC by 1.52 (credible interval: 1.37 – 2.22) in terms of relative risk (Treatment / SOC). This translates to an improvement of 8.53% (credible interval: 5.60%-19.7%) in percentage terms. In the ITT population, the IFSG +□SOC arm achieved a 47.6% closure rate versus 21.7% with SOC alone, a 25.9% absolute gain that was not statistically significant (n = 21, 95%□CI -0.02% to 0.493%, p□=□0.07, α = 0.05). In the ITT and PP population, IFSG +□SOC achieved a higher mean area reduction than SOC.

Conclusion

The interim analysis revealed that the IFSG products trended toward superiority over SOC. While the present interim analysis provides promising early results, limitations inherent to its preliminary nature warrant consideration. The alignment of these interim findings with the broader body of evidence reinforces biological plausibility and strengthens confidence that the final analysis will yield clinically meaningful results supported by high-quality evidence