We’re pleased to announce positive results from a prospective, multicentre randomised controlled trial (RCT) of Symphony, recently published in the peer-reviewed International Wound Journal.
The study found that adding Symphony to standard of care substantially improved healing outcomes for diabetic foot ulcers (DFUs).
The DFUs that were treated with Symphony and standard of care healed significantly faster; and were significantly more likely to completely close within 12 weeks, than the DFUs that were only treated with standard of care.
Key findings
- 55% of DFUs in the Symphony arm achieved complete wound closure within 12 weeks, compared with 35% in the SOC-only arm (p=0.039)
- Mean time to complete wound closure was 65.4 days for DFUs in the Symphony arm, compared with 73.2 days for DFUs in the SOC-only arm—a reduction of 7.8 days (p=0.041).
- The RCT enrolled challenging DFUs, classified as Wagner grade 1 or 2.
- The findings provide high-quality clinical evidence supporting Symphony’s effectiveness and are expected to support product differentiation, clinical adoption and evolving US reimbursement requirements.
About the study
The RCT enrolled 143 patients across 10 US sites with challenging Wagner Grade 1 or 2 DFUs. These ranged from superficial ulcers involving the full thickness of the skin to deeper ulcers extending into ligaments, tendons, joint capsules or deep fascia.
Patients were randomly assigned to receive either weekly treatment with Symphony plus standard of care or standard of care alone for up to 12 weeks or until complete wound closure.
Lead Investigator Dr David Armstrong said:
“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.”
AROA CEO Brian Ward said:
“This is a major milestone for Symphony. The study delivered clear, statistically significant results: adding Symphony to standard of care when treating DFUs increased the incidence of complete wound closure at 12 weeks by 55% and reduced mean healing time by 7.8 days.
The multicentre design and involvement of recognised key opinion leaders add credibility to the evidence and confidence in its clinical relevance. There is growing demand among clinicians, payors and reimbursement authorities for products supported by robust RCT data. With this publication, Symphony joins a relatively small group of CAMPs with Level I effectiveness data, strengthening its differentiation and commercial value proposition. We expect the findings to support momentum and deepen engagement with healthcare providers, IDNs and payors.”
About Symphony
Symphony is AROA’s Cellular, Acellular and Matrix-like Product (CAMP, or “skin substitute”), combining AROA ECM™ with high molecular weight hyaluronic acid (HMWHA). It is designed to treat hard-to-heal wounds, including DFUs and venous leg ulcers.
HMWHA is a naturally occurring polymer with anti-inflammatory properties and can retain approximately 1,000 times its weight in water, making it well suited to chronic wounds with persistent inflammation and moisture imbalance.
AROA understands that Symphony is the only commercially available CAMP incorporating HMWHA.