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. 2022 May;19(4):741-753.
doi: 10.1111/iwj.13670. Epub 2021 Aug 6.

Retrospective real-world comparative effectiveness of ovine forestomach matrix and collagen/ORC in the treatment of diabetic foot ulcers

Brandon A Bosque  1 , Christopher Frampton  2 , Abigail E Chaffin  3 , Gregory A Bohn  4 , Kevin Woo  5 , Candace DeLeonardis  6 , Brian D Lepow  7 , M Mark Melin  8 , Tobe Madu  9 , Shane G Dowling  1 , Barnaby C H May  1
Affiliations

Retrospective real-world comparative effectiveness of ovine forestomach matrix and collagen/ORC in the treatment of diabetic foot ulcers

Brandon A Bosque et al. Int Wound J. 2022 May.

Abstract

The retrospective pragmatic real-world data (RWD) study compared the healing outcomes of diabetic foot ulcers (DFUs) treated with either ovine forestomach matrix (OFM) (n = 1150) or collagen/oxidised regenerated cellulose (ORC) (n = 1072) in out-patient wound care centres. Median time to wound closure was significantly (P = .0015) faster in the OFM group (14.6 ± 0.5 weeks) relative to the collagen/ORC group (16.4 ± 0.7). A sub-group analysis was performed to understand the relative efficacy in DFUs requiring longer periods of treatment and showed that DFUs treated with OFM healed up to 5.3 weeks faster in these challenging wounds. The percentage of wounds closed at 36 weeks was significantly improved in OFM treated DFUs relative to the collagen/ORC. A Cox proportional hazards analysis showed OFM-treated wounds had a 18% greater probability of healing versus wounds managed with collagen/ORC, and the probability increased to 21% when the analysis was adjusted for multiple variables. This study represents the first large retrospective RWD analysis comparing OFM and collagen/ORC and supports the clinical efficacy of OFM in the treatment of DFUs.

Keywords: collagen/ORC; diabetic foot ulcer; ovine forestomach matrix; real-world data; retrospective.

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Conflict of interest statement

BB, SGD and BCHM are employees of Aroa Biosurgery Limited (Auckland, New Zealand). BCHM is a shareholder of Aroa Biosurgery Limited. TM is an employee of Net Health (Pittsburgh, Pennsylvania). AEC, GAB, KW, BDL, MMM have received educational grants from Aroa Biosurgery Limited. CF, CDL and TM provided consulting services to Aroa Biosurgery Limited.

Figures

FIGURE 1
FIGURE 1
Data filtering and sample size (wound and patient) used in the study
FIGURE 2
FIGURE 2
Kaplan‐Meir survival curves of OFM and collagen/ORC treated wounds (HR = 1.18 [95% CI: 1.06, 1.30], P = .002)
FIGURE 3
FIGURE 3
Median time to wound closure. Error bars represent upper and lower 95% confidence intervals. ns, not significant; *P < .05; **P < .01; ***P < .001
FIGURE 4
FIGURE 4
Percentage of wounds closed. Error bars represent upper and lower 95% confidence intervals. ns, not significant; *P < .05; **P < .01; ***P < .001
FIGURE 5
FIGURE 5
Forest plot of Hazards ratios (HR) from unadjusted and adjusted CPH analysis. Error bars represent that upper and lower 95% CI. Dotted line represents HR = 1.0
See this image and copyright information in PMC

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