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IJTR · 2025

A multicenter, prospective randomized controlled modified dual platform trial evaluating several CAMPs and standard of care vs. standard of care alone in the management of nonhealing diabetic foot ulcers and venous leg ulcers

Serena, T., Tramelli, B., & King, E.

International Journal of Tissue Repair (IJTR), TIGERCAMP trial design

In brief

This abstract describes the design of TIGERCAMP, a multicenter randomized controlled trial using a modified dual platform design to compare several cellular, acellular, and matrix-like products (CAMPs) plus standard of care with standard of care alone for nonhealing diabetic foot ulcers and venous leg ulcers. The first phase evaluates two placental allografts (ACAPatch and caregraFT) for each ulcer type, with complete wound closure within 12 weeks as the primary endpoint. No results are reported yet; the authors plan separate pooled analyses for each ulcer type and a master publication comparing all pooled product arms with pooled standard of care.

SerenaGroup is running this trial.

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

Abstract

A multicenter, prospective randomized controlled modified dual platform trial evaluating several cellular, acellular, and matrix-like products (CAMPs) and standard of care versus standard of care alone in the management of nonhealing diabetic foot ulcers and venous leg ulcers (TIGERCAMP) Thomas Serena1 MD | Brianna Tramelli1 | Emily King1 MS 1 SerenaGroup, Inc., Cambridge, MA

Keywords

Interim analysisdiabetic foot ulcervenous leg ulcerchronic woundswound coveringwound closurecellular acellular matrix-like productsplatform trialcase studyclinical trial design