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IJTR · 2025

Evaluation of cellular, acellular, and matrix-like products in the management of nonhealing venous leg ulcers

Serena, T.E., Tramelli, B., Dunn, M., King, E., & Shi, D.

International Journal of Tissue Repair (IJTR), interim analysis, STABLECAMP trial (VLU)

In brief

This interim analysis of the STABLECAMP multicenter randomized controlled platform trial compared several cellular, acellular, and matrix-like products plus standard of care (SOC) with SOC alone for nonhealing venous leg ulcers, with complete wound closure at 12 weeks, confirmed by blinded independent review, as the primary endpoint. In the intent-to-treat population, the dual layer amniotic membrane allograft arm had a 50% closure rate versus 16.7% with SOC alone, a statistically significant difference (p=0.018), while no other product arm was significant in that population and no arm was significant in the per protocol population. The authors conclude that the placental membrane products trended toward superiority over SOC at this interim stage.

SerenaGroup is running this trial for Stability Biologics.

Plain-language summary by SerenaGroup. See the full text for complete methods and results.

Abstract

Evaluation of cellular, acellular, and matrix-like products in the management of nonhealing venous leg ulcers: an interim analysis of STABLECAMP Thomas E Serena,1 MD | Brianna Tramelli1 | Madison Dunn1 | Emily King1 MS | Dereck Shi,1 MS SerenaGroup Inc., Cambridge, MA, USA 1

Keywords

Cellular acellular and matrix-like productsinterim analysischronic woundsvenous leg ulcer