Publications library Abstract
IJTR · 2025
Serena, T.E., Tramelli, B., King, E., Shi, D., Dunn, M., Mehta, M., Simon, D., & Pavelescu, R.A.
International Journal of Tissue Repair (IJTR), interim analysis, STABLECAMP trial (DFU)
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 diabetic foot 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 amnion/chorion membrane allograft arm had a 58.3% closure rate versus 13.3% with SOC (p=0.001), and in the per protocol population the four-layer amniotic membrane allograft arm had a 63.6% closure rate versus 23.8% with SOC (p=0.027); both differences were statistically significant, and all other product arms were not. These are interim results based on small numbers (n=12 and n=11 as reported).
SerenaGroup is running this trial for Stability Biologics.
Plain-language summary by SerenaGroup. See the full text for complete methods and results.
