Matrix-Based Skin Substitute Improves Closure of Diabetic Foot Ulcers

Diabetic foot ulcers are hard-to-heal wounds that can persist because of chronic inflammation and moisture imbalance. When standard care alone does not achieve timely closure, clinicians may use adjunctive skin substitutes to support healing. Randomized clinical evidence can help guide selection among these therapies. A new extracellular matrix–hyaluronic acid skin substitute has now shown higher 12-week closure rates and faster healing when added to standard care.

Symphony from Aroa Biosurgery (Auckland, New Zealand) is a Cellular, Acellular and Matrix-like Product (CAMP), also described as a "skin substitute", designed for hard-to-heal wounds such as diabetic foot ulcers and venous leg ulcers. The product is intended for use as an adjunct to standard wound care. The multicenter findings were published in the International Wound Journal.

The technology combines AROA ECM with high molecular weight hyaluronic acid (HMWHA). HMWHA is a naturally occurring polymer with anti-inflammatory properties and the ability to retain approximately 1,000 times its weight in water, characteristics that align with the needs of chronic wounds affected by persistent inflammation and moisture imbalance. While Cellular, Acellular and Matrix-like Products (CAMPs) are commonly used to treat diabetic foot ulcers, AROA understands Symphony to be the only commercially available product that incorporates HMWHA.

A prospective, randomized controlled trial enrolled 143 patients across 10 U.S. sites with Wagner Grade 1 or 2 diabetic foot ulcers. Participants were assigned to receive weekly Symphony plus standard of care or standard of care alone for up to 12 weeks or until complete wound closure. The study met its objectives and was conducted across a range of ulcer severities, from full-thickness skin involvement to deeper ulcers extending into ligaments, tendons, joint capsules or deep fascia.

Symphony plus standard care achieved complete wound closure in 55% of ulcers at 12 weeks versus 35% with standard care alone (p=0.039). Mean time to complete closure was reduced by 7.8 days, from 73.2 days with standard care alone to 65.4 days with Symphony plus standard care (p=0.041). The findings provide high-quality clinical evidence supporting Symphony’s effectiveness and are expected to support clinical adoption and evolving U.S. reimbursement requirements.

“New technologies and high-quality randomised clinical evidence are essential if we are to continue improving outcomes for patients with diabetic foot ulcers. The Symphony trial demonstrates that combining a novel extracellular matrix bioscaffold with high molecular weight hyaluronic acid can significantly improve wound healing when added to good standard of care. Studies like this help clinicians make informed treatment decisions based on robust evidence,” said Dr David Armstrong, lead investigator.

Related Links
Aroa Biosurgery