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

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.

Varying Properties of Extracellular Matrix Grafts Impact Their Durability and Cell Attachment and Proliferation in an In Vitro Chronic Wound Model

“…To build on the current evidence base and further elucidate how processing methodologies (e.g., layering and crosslinking) impact key properties, we utilized commercially available products constructed of SIS and OFM and evaluated matrix structure and protease attenuation; this analysis was complimented by the development and application of an in vitro degradation chronic wound model to study scafold degradation dynamics and functionality [4,[29][30][31]. Here, both SIS and OFM were able to attenuate MMPs; however, structural and functional properties determined the magnitude of MMP reduction.…”

“…Te products in this study are both native collagen ECMs, with SIS undergoing layering and an additional chemical crosslinking process. Both tissue sources have been shown clinically to support progression through the wound healing phases [29,30].…”

Retrospective Data Analysis of the Use of an Autologous Multilayered Leukocyte, Platelet, and Fibrin Patch for Diabetic Foot Ulcers Treatment in Daily Clinical Practice

“…Although RWD analysis is a recognized and validated methodology to support real-world evidence, working with secondary data increases the measurement complexity in comparison with primary data collected in RCTs involving a selected study population. [16][17][18]23 The strength of this retrospective study is the analysis of a challenging patient population with comorbidities and hard-to-heal DFUs, which represents most patients attending the facility centers. The authors obtained helpful information to complement existing evidence for MLPF patch treatment with the centers' own experiences.…”

“…Real-world data (RWD) refers to data collected from sources others than RCTs that can be used to support clinical interpretation of how products act in a diverse patient population, thus providing a line of complementary real-world evidence. [16][17][18] The main objective of this retrospective data analysis was to describe the effectiveness of the MLPF patch when used in the real-world clinical setting of two amputation preventive centers in the US.…”

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“…Currently, NPWT is a mainstay to promote granulation tissue and expedite wound healing in abdominal defects [4]. NPWT can provide coverage to exposed viscera, protect the site from bacterial contamination, and manage wound a range of contaminated defects including hidradenitis suppurativa [19], pilonidal sinus [20], chronic lower extremity defects [21,22] and necrotizing soft tissue infections [23]. In the search for new cost-effective options to improve healing of contaminated traumatic wounds the authors has begun to use OFM-based biologic grafts in combination with NPWT across a range of complex soft tissue defects.…”