IJTR · 2025
Evaluation of intact fish skin grafts plus standard of care in the treatment of venous leg ulcers: research article
Serena, T.E., Tramelli, B., Booker, B., King, E., Shi, D., & Lantis, J.C.
International Journal of Tissue Repair (IJTR), interim analysis, THOR trial
In brief
This interim analysis of THOR, a randomized controlled multicenter trial (NCT06693570), compared an intact fish skin graft plus standard of care (SOC) with SOC alone for hard-to-heal venous leg ulcers, with complete closure within 12 weeks as the primary endpoint. Among 44 patients who had completed the study (21 graft, 23 SOC), closure rates were 47.6% versus 21.7% in the intent-to-treat analysis (p = 0.07) and 44.4% versus 23.5% in the per protocol analysis (p = 0.193), so neither difference was statistically significant. Mean percent area reduction was higher with the graft (75.00 versus 41.68 in the intent-to-treat analysis, outliers excluded), and the authors note that the interim data have limited statistical power.
SerenaGroup is running this trial for Kerecis.
Plain-language summary by SerenaGroup. See the full text for complete methods and results.
Abstract
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. Results: The statistical analysis revealed that the treatment arm trended toward 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 demonstrated a positive trend favoring IFSG products over SOC alone. 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.
Keywords
Cellular acellular and matrix-like productsvenous leg ulcerinterim analysischronic woundsclinical trial design
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