A wound that has been open for months needs somewhere for healing to take hold.
That is the idea behind a bioscaffold: give cells a structure they can move into and build upon. Add a component designed to help maintain moisture, and the biological question becomes a practical one: does that combination help more wounds close?
Our newly published randomized controlled trial in International Wound Journal puts that question to the test. It evaluated a composite of ovine forestomach matrix and high-molecular-weight hyaluronic acid, or OFM-HA, alongside standard care for chronic full-thickness foot wounds in people with diabetes.
The headline: 46% of wounds closed by 12 weeks with OFM-HA plus standard care, compared with 24% with standard care alone. That is an encouraging result, with important details behind it.
A scaffold, a moisture partner, and a stubborn wound
Ovine forestomach matrix is a sheep-derived extracellular matrix with the cells removed. Think of it as biological scaffolding: an existing tissue framework that can support the body’s repair work. Hyaluronic acid is a naturally occurring component of the extracellular matrix with an important role in retaining water.
The composite studied here, Symphony, brings OFM together with high-molecular-weight hyaluronic acid. Laboratory work provides a rationale for supporting cell movement, moisture balance, and a more favorable wound environment. This clinical trial tested whether the combined product improved closure; it did not measure those mechanisms or isolate what hyaluronic acid contributed on its own.
For readers following our “Control-Alt-Delete” discussion of the chronic wound, this fits a familiar theme: prepare the wound bed and give healing a better environment in which to work.
What the trial actually tested
Across 10 sites, 143 participants were randomized: 70 to OFM-HA plus standard care and 73 to standard care alone. All participants in the main analysis had type 2 diabetes. Eligible wounds had been present for 4–52 weeks, measured 1–25 cm², and met the study’s perfusion and infection criteria. Wounds that shrank by 30% or more during the two-week standard-care run-in were excluded. These were wounds that still needed help.
The protocol included cleansing, sharp debridement, dressings, and pressure relief with a removable boot or total contact cast. The control regimen used a collagen/alginate dressing. Patients were evaluated weekly; OFM-HA recipients in the main analysis received a mean of 8.6 applications.
“Healed” meant 100% epithelialization with no drainage, followed by a confirmation visit approximately two weeks later. Closure assessment included a blinded assessor and independent image review. Patients and treating clinicians were not described as blinded.
The numbers worth knowing
- Complete closure at 12 weeks: 31 of 68 wounds (46%) with OFM-HA plus standard care, versus 17 of 72 (24%) with standard care alone; p = 0.008
- Absolute difference: about 22 percentage points in the modified intention-to-treat analysis. The observed proportion healed was nearly twice as high with OFM-HA
- Adjusted analysis: estimated closure was 43% versus 26% after adjustment for initial wound area and prior ulcer recurrence; p = 0.045
- Time-to-closure analysis: the Kaplan–Meier comparison favored OFM-HA during the 12-week observation period; log-rank p = 0.023
The primary analysis was modified intention-to-treat: three participants were excluded after randomization because of eligibility or treatment-assignment errors. That left 140 people in the main comparison. Missing closure outcomes associated with withdrawal, death, or an amputation obliterating the index ulcer were counted as not healed.
Keep the enthusiasm. Keep the denominator.
A useful trial should help us ask better questions as well as answer the first one. Several details matter here:
- Withdrawal differed between groups. Ten of 68 participants (14.7%) withdrew or were withdrawn from OFM-HA plus standard care, compared with 20 of 72 (27.8%) from standard care alone. Counting missing outcomes as unhealed does not eliminate potential bias from that difference
- The adjusted result was close to the statistical threshold. The supportive adjusted analysis remained significant at p = 0.045, but it deserves a measured reading
- The population was selected. Overt infection and osteomyelitis were exclusion criteria. Meeting the perfusion criteria did not mean every participant was free of peripheral artery disease. These findings should not be generalized to every infected or ischemic foot wound
- Other benefits remain unproven. Wound-area reduction was not statistically significant. Under the prespecified testing hierarchy, pain and quality-of-life findings remained descriptive. Longer-term recurrence, amputation reduction, and cost-effectiveness were not established
Adverse events were common in both groups: 50% of OFM-HA recipients and 51% of controls experienced at least one. There were 56 events versus 63, including one death in each group. The investigators reported no unexpected safety-related occurrences.
Many hands, one practical question
This work connects clinical research across the United States with bioscaffold development in Auckland, New Zealand. The author team brings together USC, Brigham and Women’s Hospital, Northwestern, Mount Sinai, Drexel, the Center for Clinical Research, Barry University, the Professional Education and Research Institute (PERI), and Strategic Solutions.
My coauthors are Dennis Orgill, Robert Galiano, John Lantis, the late + great Paul Glat, Alexander Reyzelman, Robert Snyder, Adam Isaac, Marissa Carter, and Charles Zelen. Behind the author list are the study coordinators, clinical teams, and participants who make a question like this testable. We also recognize the contributions of our late colleague Paul Glat.
Limb preservation is a team sport. So is building the evidence that helps those teams decide what to do next.
From wound closure to more time living
For a person living with an open foot wound, closure is a meaningful milestone. The next challenge is keeping it closed while preserving mobility and independence. That is why offloading, vascular assessment, infection management, and follow-up remain central to the story.
This trial gives us encouraging randomized evidence for one composite matrix within a defined care regimen. The longer-term goal remains the one that guides our work: more ulcer-free, hospital-free, activity-rich days.
Give healing a foothold. Then help people keep moving.
Read the study
Funding and disclosure: Aroa Biosurgery funded the study through a research grant to PERI. I received research funds from PERI for study design and administration and manuscript work. The paper details research-funding relationships for several coauthors and institutions; Charles Zelen is PERI’s medical director, and Adam Isaac declares no conflicts of interest.
#DiabeticFoot #WoundHealing #CAMPs #LimbPreservation #ActAgainstAmputation
Featured image: original AI-generated conceptual illustration; not a depiction of the trial device or a proven mechanism of action.
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