Use of a Purified Reconstituted Bilayer Matrix in the Management of Non-Healing Diabetic Foot Ulcers: A Prospective Randomized Controlled Multicenter Clinical Trial

Patients with diabetic foot ulcers (DFUs), in particular when unresponsive to standard wound care, face serious risks of severe complications, including infection and amputation. The management of DFUs is associated with increasing social and financial burdens. In a previous series of 10 patients the authors evaluated a unique Purified Reconstituted Bilayer Matrix (PRBM) and found the material to be easy to apply as well as safe and efficacious in the treatment of chronic DFUs1. PRBM is an advanced acellular bilayer scaffold derived from two distinct porcine tissue sources2. The bilayer is designed with a highly porous layer that is applied in direct contact with the wound bed and a second compact outer layer that is mechanically robust. The lower porous layer is designed for close adaptation to the wound bed and immediate wound fluid uptake due to its sponge-like architecture and hydrophilic properties1. The chemical composition, which is similar to native extracellular matrix, is intended to modulate matrix metalloproteinase activity and serve as a scaffold for cellular ingrowth and eventual revascularization3. The thin upper compact layer facilitates easy handling and is intended to provide support and protection to the wound site3. Its chemical composition is designed to bind and preserve growth factors and guide re-epithelialization by mimicking the structure of the basement membrane3.

To evaluate the efficacy and safety of PRBM compared to standard of care (SOC) in treating non-healing DFUs the authors initiated an IRB-approved 40-patient prospective randomized controlled multicenter clinical trial. Patients with Wagner grade 1 wounds are first pre-screened for a 2-week period in which all patients receive a collagen-alginate dressing as part of a standard of care protocol.  Patients who do not heal during pre-screening are randomized to receive a weekly application of either PRBM or SOC. Wounds are evaluated, measured, photographed and grafted if necessary each week for up to 12 weeks. The primary study endpoint is complete wound closure at 12 weeks. Secondary endpoints include time to heal, percent area reduction, product wastage and cost to closure

At the time of abstract submission 46 patients have signed consent. Six patients were pre-screened out due to wound closure during the pre-screening period, and 40 patients have been randomized to PRBM or SOC treatment. 39 patients have completed treatment and evaluation. No product-related adverse events have been observed so far. The authors intend to present the final results of this level I RCT study at the SAWC fall 2020 symposium.

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References (if applicable): (1) Armstrong et al. An observational pilot study using a purified reconstituted bilayer matrix to treat non-healing diabetic foot ulcers. Int Wound J. 2020. 17(4):966-973.
(2) Instructions for use, Geistlich Derma-Gide®. Geistlich Pharma AG, Wolhusen, Switzerland
(3) Armstrong et al. Functional Properties of a Purified Reconstituted Bilayer Matrix Designed to Support Natural Wound Healing Activities. In preparation.