IJTR · 2025
Evaluation of human placental-based cellular, acellular and matrix-like products (CAMPs) in the management of nonhealing diabetic foot ulcers
Serena, T., Tramelli, B., King, E., Shi, D., Breisinger, K., Neil, M., Frania, S., Iosue, H., Namen, W., Patel, K., Salameh, M., York, G., Silver, G., Gatlin-James, S., Calderone, M., & Shaarawy, R.
International Journal of Tissue Repair (IJTR), interim analysis, CAMPSTIM trial
In brief
This interim analysis of the CAMPSTIM multicenter randomized controlled platform trial compared a fenestrated dehydrated complete human placental membrane allograft (Relese) plus standard of care (SOC) with SOC alone for hard-to-heal diabetic foot ulcers, with complete closure at 12 weeks as the main outcome. In the intent-to-treat analysis the allograft arm (n=53) had an 11.6% absolute gain in closure rate over SOC alone (n=60), which was not statistically significant (p=0.14), and the per protocol gain of 16.8% was also not significant (p = 0.10). Median percent area reduction over 12 weeks was 71.1% with the allograft versus 47.1% with SOC, and safety was comparable between groups with no product-related adverse events reported.
SerenaGroup is running this trial for Stimlabs.
Plain-language summary by SerenaGroup. See the full text for complete methods and results.
Abstract
Evaluation of human placental-based cellular, acellular and matrix-like products (CAMPs) in the management of nonhealing diabetic foot ulcers: an interim analysis of the CAMPSTIM clinical trial Thomas Serena1 MD | Brianna Tramelli1 | Emily King1 MS | Dereck Shi1 MS | Kristy Breisinger1 | Meghan Neil1 NP-C | Stephen Frania2 DPM | Hayley Iosue2 DPM | William Namen3 DPM | Keyur Patel4 DO | Mohammad Salameh4 MD | Glenn York5 DPM | George Silver6 DPM | Sherocko Gatlin-James7 FNP | Michael Calderone8 DPM | Rami Shaarawy9 MD 1 SerenaGroup, Inc., Cambridge, MA | 2Ohio Foot & Ankle Specialists, Mentor, OH | 3Namen Podiatry, Symphony Research, Jacksonville, FL | 4Three Rivers Wound and Hyperbaric Center, North Port, FL | 5CHI Health Lakeside, SerenaGroup, Omaha, NE | 6Greater Orange Foot Care, Orange, TX | 7iHealth Clinical, Lilburn, GA | 8Inspira Medical Center, Vineland, NJ | 9Valiance Clinical Research Northridge, Northridge, CA, USA
Keywords
Cellular acellular matrix-like productschronic woundsdehydrated complete human placental membranediabetic foot ulcerinterim analysistissue regeneration
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