Comparative effectiveness of porcine placental extracellular matrix against other cellular, acellular and matrix-like products in diabetic foot ulcers from the Medicare database.

Diabetic foot ulcers (DFUs) are often hard to heal and may require advanced treatment with cellular, acellular and matrix-like products (CAMPs). This retrospective cohort study examines the Medicare fee-for-service population to compare clinical outcomes and health resources utilization in patients receiving porcine placental extracellular matrix (PPECM [InnovaMatrix AC, Convatec Triad Life Sciences, LLC, TN, USA]) against other CAMPs. The Center for Medicare & Medicaid Services 100% Research Identifiable Files database was searched for potentially eligible patients using relevant ICD-10 diagnosis codes between 1 January 2020 and 31 December 2023. Patients with confirmed diagnoses of DFU and non-pressure chronic ulcers were selected for further evaluation. Eligible patients were categorized into groups according to treatment received: PPECM, PPECM's 510(k) predicate† (OASIS Wound Matrix, Cook Biotech Inc., IN, USA), or other similar CAMPs (OSC [Marigen Shield and Omega3 (Kerecis, Ísafjörður, Iceland); Integra Dermal Regeneration Template and Primatrix (Integra LifeSciences, NJ, USA); GraftJacket (Stryker, MI, USA); Theraskin and Dermacell (LifeNet Health, VA, USA); FlexHD/AllopatchHD and Amnioband (MTF Biologics, NJ, USA); Grafix/Stravix (Smith + Nephew, MA, USA); Epicord and Epifix (MiMedx, GA, USA); Affinity, Apligraf and Dermagraft (Organogenesis, MA, USA)]). Patient demographics, comorbidities and ulcer location were assessed for cohort homogeneity and balanced via inverse probability of treatment weighting, to adjust for potential confounding factors when comparing health outcomes. There were 940,910 patients with a DFU diagnosis; of these, 738,124 (78.4%) also had same-day diagnosis of a non-pressure chronic ulcer. After application of eligibility criteria, there were a total of 34,664 patients with DFUs with 37,380 episodes of care that included one of the CAMP treatments (PPECM: number of patients (n) = 186, number of episodes (e) = 186; PPECM's 510(k) predicate: n = 369, e = 370; and OSC: n = 33,858, e = 36,559). In the inverse probability of treatment weighting-balanced model, patients with OSC episodes were 1.309-times more likely to undergo outpatient amputation than those with PPECM (95% CI: 1.251-1.371, p < 0.0001). Bacteremia was 2.75-times more likely in OSC episodes than in PPECM episodes (95% CI: 2.471-3.053, p < 0.0001). PPECM episodes had significantly fewer outpatient hospital visits compared with both OSC and PPECM's 510(k) predicate (5.84, 8.79 and 10.24, respectively, p < 0.0001). There were no differences in physician office visits or hospital admissions. The findings suggest that PPECM performed clinically as well as or better than other well-established CAMPs. Notably, episodes of DFU care that involved PPECM were associated with significantly fewer outpatient amputations, fewer episodes of bacteremia, and fewer outpatient hospital visits. These data suggest that PPECM offers a clinically competitive treatment option for patients with DFUs.