Systematic review of cellular, acellular and matrix-like products (CAMPs) and indirect treatment comparison between cellular/acellular and amniotic/non-amniotic grafts in the management of diabetic foot ulcers.

Abstract

This Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)-compliant review focuses on the efficacy of cellular, acellular and matrix-like products (CAMPs) in the management of diabetic foot ulcers based on published randomized control trials (RCTs). While CAMPs have been incorporated into the clinical algorithm for chronic wounds, evidence is lacking to comparatively evaluate the efficacy of these products. Level 1 RCT studies are the gold standard to evaluate efficacy of different treatment approaches, however, due to differences in surgical techniques, patient demographics and compliance, standard of care outcomes in the wound care space can vary significantly between different randomized controlled trials, making it difficult to compare them against each other. To mitigate variability between different RCTs, wound closure outcomes can be reported as risk ratios. This review of all currently published RCTs (with similar trial design) in diabetic foot ulcer (DFU) patients and risk ratios, confirms that CAMPs adjunct to standard of care result in statistically superior wound closure outcome in diabetic foot ulcers, when compared to standard of care alone, with a Risk Ratio (RR) of 1.72 [1.56, 1.90], p< 0.00001. Enough evidence is still lacking to determine a statistical difference between broad categories of cellular/acellular and amniotic/non-amniotic CAMPs; and hence decision makers should consider published head-head comparative studies, real-world evidence and cost-effectiveness evidence between individual CAMPs to decide on which to use in practice.