Journal of wound care · 2026
Lower limb amputation rates among Medicare beneficiaries with diabetic foot ulcers managed with and without native collagen matrix plus PHMB antimicrobial.
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Desai Urvi, Rice J Bradford, Kongara Serena, Kirsner Robert S
Аннотация
OBJECTIVE: This study compared rates of non-traumatic lower limb amputations ('amputations') among Medicare beneficiaries with diabetic foot ulcers (DFUs) who initiated purified native type 1 collagen matrix plus polyhexamethylene biguanide (PHMB) antimicrobial (PCMP) versus those beneficiaries who did not receive PCMP.
METHOD: In this retrospective matched cohort study, two groups of beneficiaries with DFUs were retrospectively identified from 100% Medicare Fee-for-Service Standard Analytic Files (Quarter 1 2015-Quarter 3 2023)-those receiving PCMP within six months of DFU diagnosis (index date=first PCMP claim) and those who did not receive PCMP. Beneficiaries were matched 1:1. Using Wilcoxon signed-rank tests, six-month post-index amputation rates were compared. Stratified analysis evaluated amputation rates among beneficiaries initiating PCMP within 45, 60 or 90 days of DFU diagnosis, with follow-up applications every 7-14 days for one month.
RESULTS: Before matching, beneficiaries receiving PCMP (n=10,939) had greater disease severity, as indicated by longer duration of active ulceration and higher amputation rates in the six months pre-index date than those beneficiaries who never received PCMP (n=657,233). After matching, baseline characteristics were well balanced (n=10,862). During follow-up, beneficiaries receiving PCMP had lower six-month amputation rates than those in the matched non-PCMP cohort (9.9% versus 12.2%, respectively; p<0.001). Beneficiaries with earlier initiation of PCMP within 45, 60 or 90 days of diagnosis had lower six-month amputation rates (4.0%, 4.1% and 4.8%, respectively) compared with non-PCMP recipients (8.4%; all p<0.001).
CONCLUSION: PCMP was disproportionately used in the management of beneficiaries with more complex DFUs/wound care needs. After adjusting for baseline differences, PCMP use was associated with lower rates of lower limb amputations, particularly with earlier initiation within 90 days of DFU diagnosis.
METHOD: In this retrospective matched cohort study, two groups of beneficiaries with DFUs were retrospectively identified from 100% Medicare Fee-for-Service Standard Analytic Files (Quarter 1 2015-Quarter 3 2023)-those receiving PCMP within six months of DFU diagnosis (index date=first PCMP claim) and those who did not receive PCMP. Beneficiaries were matched 1:1. Using Wilcoxon signed-rank tests, six-month post-index amputation rates were compared. Stratified analysis evaluated amputation rates among beneficiaries initiating PCMP within 45, 60 or 90 days of DFU diagnosis, with follow-up applications every 7-14 days for one month.
RESULTS: Before matching, beneficiaries receiving PCMP (n=10,939) had greater disease severity, as indicated by longer duration of active ulceration and higher amputation rates in the six months pre-index date than those beneficiaries who never received PCMP (n=657,233). After matching, baseline characteristics were well balanced (n=10,862). During follow-up, beneficiaries receiving PCMP had lower six-month amputation rates than those in the matched non-PCMP cohort (9.9% versus 12.2%, respectively; p<0.001). Beneficiaries with earlier initiation of PCMP within 45, 60 or 90 days of diagnosis had lower six-month amputation rates (4.0%, 4.1% and 4.8%, respectively) compared with non-PCMP recipients (8.4%; all p<0.001).
CONCLUSION: PCMP was disproportionately used in the management of beneficiaries with more complex DFUs/wound care needs. After adjusting for baseline differences, PCMP use was associated with lower rates of lower limb amputations, particularly with earlier initiation within 90 days of DFU diagnosis.