Symphony skin substitute improves diabetic foot ulcer healing in 143-patient trial
Adding Symphony to standard of care led to complete wound closure in 55% of diabetic foot ulcers within 12 weeks, compared with 35% for standard care alone, according to a randomized controlled trial published in the International Wound Journal. Aroa Biosurgery Limited (ASX: ARX), which makes the product, announced the results.
- Randomized controlled trial of Symphony enrolled 143 patients at 10 U.S. sites and was published in the International Wound Journal.
- 55% of diabetic foot ulcers closed within 12 weeks with Symphony plus standard of care, versus 35% with standard care alone (p=0.039).
- Mean time to closure was 65.4 days versus 73.2 days, a 7.8-day reduction (p=0.041).
- Aroa says the results should support differentiation, adoption and U.S. reimbursement requirements.
What the trial found
The prospective, multicenter study enrolled 143 patients across 10 U.S. sites. Patients were randomly assigned to receive either weekly Symphony plus standard of care, or standard of care alone, for up to 12 weeks or until complete wound closure.
According to Aroa, 55% of diabetic foot ulcers (DFUs) treated with Symphony achieved complete closure within 12 weeks, against 35% in the standard care group (p=0.039). Mean time to complete closure was also shorter: 65.4 days with Symphony plus standard of care, compared with 73.2 days with standard of care alone, a reduction of 7.8 days (p=0.041).
Who was studied
The trial enrolled patients with Wagner Grade 1 or 2 DFUs, which Aroa describes as challenging. These range from ulcers involving the full thickness of the skin to deeper ulcers extending into ligaments, tendons, joint capsules or deep fascia.
The full study is titled A Composite Ovine Forestomach Matrix and Hyaluronic Acid CAMP for the Treatment of Full Thickness Wounds of the Foot in People with Diabetes: A Randomized Controlled Trial. It is available on PubMed at https://pubmed.ncbi.nlm.nih.gov/42823610/.
About Symphony
Symphony is Aroa's Cellular, Acellular and Matrix-like Product (CAMP, or "skin substitute"). It combines AROA ECM with high molecular weight hyaluronic acid (HMWHA) and is designed to treat hard-to-heal wounds such as DFUs and venous leg ulcers.
Aroa says HMWHA is a naturally occurring polymer with anti-inflammatory properties and can retain approximately 1,000 times its weight in water. The company argues this makes it well suited to chronic wounds with persistent inflammation and moisture imbalance. While CAMPs are commonly used to treat DFUs, Aroa understands Symphony is the only commercially available product incorporating HMWHA.
Comments and what it means
Lead investigator Dr David Armstrong said that "new technologies and high-quality randomised clinical evidence are essential if we are to continue improving outcomes for patients with diabetic foot ulcers." He added that studies like this "help clinicians make informed treatment decisions based on robust evidence."
Aroa CEO Brian Ward called the result "a major milestone for Symphony" and said the multicentre design and involvement of recognised key opinion leaders strengthen the evidence's credibility. He said clinicians, payors and reimbursement authorities increasingly demand robust RCT data, and that the publication places Symphony among a small group of CAMPs with Level I effectiveness data.
The company says the findings are expected to support product differentiation, clinical adoption and evolving U.S. reimbursement requirements. Those expectations are Aroa's own, and the source does not give details on pricing, availability or regulatory steps.
