A Bayesian hierarchical meta-analysis of CAMPS versus standard of care for diabetic foot ulcers: systematic review of evidence from Medicare’s 2024 final Local Coverage Determinations

Abstract

Aims: To quantify the treatment effects of cellular, acellular and matrix-like products (CAMPs) on diabetic foot ulcer (DFU) healing, based on the 35 randomized controlled trials (RCTs) cited in Medicare’s 2024 Local Coverage Determinations (LCDs).

Methods: We extracted healing outcome data from all 35 RCTs and applied a Bayesian hierarchical beta-binomial model to estimate product-specific and pooled healing probabilities, and risk ratios. We used posterior prediction to account for heterogeneity and to impute missing standard of care (SOC) comparators. Predicted outcomes were standardized to a 12-week follow-up and a hypothetical trial size of 100 participants (50 per arm), ensuring comparability across heterogeneous study designs.

Results: All CAMPs showed improved healing relative to SOC. The pooled posterior mean risk ratio was 2.0 (95% credible interval (Crl)): 1.69–2.38), indicating a doubling of healing likelihood. Product-specific risk ratios ranged from 1.74 to 2.30, with minimal posterior probability near the null, supporting consistent treatment benefit across products.

Conclusions: CAMPs consistently show superior healing outcomes compared to SOC in promoting DFU healing. This quantitative synthesis clarifies the evidence underpinning Medicare’s coverage decisions and provides a statistical benchmark for clinicians, sponsors, and payers in evaluating CAMPs-based therapies.