Phase 3 Trial Demonstrates Autologous Cutaneous Multicellular Units (Acmu) Significantly Improve Wound Closure Rates and Reduce Severe Complications in Non-healing Diabetic Foot Ulcers
First-to-Podium research presented at HMP Global’s 2026 Symposium on Advanced Wound Care (SAWC) Fall
Key Findings:
- Data from 120 randomized patients with non-healing diabetic foot ulcers (DFUs) shows that ACMU plus standard of care (SOC) doubled complete wound closure rates at 12 weeks compared to SOC alone.
- Patients treated with ACMU achieved significantly greater percent area reduction (PAR) at 12 weeks and reached a median time to closure of 85 days, whereas the median closure time for the SOC control group was not estimable.
- ACMU therapy drastically reduced limb-threatening complications, cutting index ulcer infections to 8.5% vs. 25.0%, index ulcer osteomyelitis to 1.7% vs. 15.0%, and index ulcer-related amputations to 0% vs. 5.0%.
- The findings demonstrate that ACMU application provides durable, definitive tissue regeneration in chronic, high-risk diabetic foot ulcers.
A new study presented today during the First-to-Podium program at the 2026 Symposium on Advanced Wound Care (SAWC) Fall reported groundbreaking clinical results from the Phase 3 COVER DFUS II trial, demonstrating that an investigational autologous biologic (ACMU) derived from a patient's own skin significantly accelerates wound closure while preventing devastating limb complications in non-healing diabetic foot ulcers (DFUs). The findings were presented by Robert S. Kirsner, MD, PhD, FAAD, Chair of the Dr. Phillip Frost Department of Dermatology and Cutaneous Surgery at the University of Miami Miller School of Medicine. Researchers compared ACMU plus SOC (including offloading, sharp debridement, and moist wound therapy) versus SOC alone in adults with non-healing Wagner 1 DFUs. Despite adherence to gold-standard wound protocols, non-healing DFUs frequently persist and lead to infections and limb loss. This multicenter, randomized controlled trial confirms that ACMU delivers decisive clinical efficacy in historically difficult-to-heal DFU patient populations.
Overcoming Therapeutic Plateaus in Complex Diabetic Foot Ulcers
Current treatment protocols for non-healing DFUs frequently hit a therapeutic ceiling, leaving patients exposed to prolonged open wounds and repeat hospitalizations. In the COVER DFUS II trial (NCT06140303), investigators evaluated 120 adult patients randomized 1:1 across 17 clinical sites to evaluate index ulcer closure within 12 weeks in the intent-to-treat population. The study population had complex, long-term conditions typical of real-world care. Patients had a mean baseline ulcer area of 3.36 cm² vs. 3.25 cm², a mean wound duration exceeding nine months (309 days for ACMU vs. 266 days for SOC), an average HbA1c of approximately 8%, a prior amputation history of roughly 60%, and documented histories of prior index ulcer infection (~27%) and osteomyelitis (~17%). Designed primarily as a single-application therapy, only 18.3% of participants required an allowable second application.
The trial met its primary endpoint with high statistical significance, achieving complete 12-week closure in 53.3% of ACMU-treated patients compared to 26.7% receiving SOC alone (p=0.0014). Percent area reduction was markedly superior in the ACMU cohort throughout the 12-week evaluation period (p=0.0028), with distinct advantages seen across ulcer area strata: 62% vs. 34% closure in 1–3 cm² wounds (p=0.01) and 46% vs. 8% closure in 3–8 cm² wounds (p=0.04). Beyond wound closure, ACMU demonstrated an exceptional safety profile with no adverse events directly attributed to the biologic, while significantly mitigating severe downstream pathology. Compared to standard of care, ACMU-treated patients experienced fewer treatment-emergent adverse events leading to discontinuation (1.7% vs. 10.0%), a marked reduction in index ulcer infections (8.5% vs. 25.0%, p=0.014), an eight-fold reduction in index ulcer osteomyelitis (1.7% vs. 15.0%, p=0.0082) and no ulcer-related amputations (0% vs. 5.0%).
Patient access to advanced autologous biologics should be prioritized to prevent costly complications and limb loss
The study’s findings spotlight that chronic, non-healing ulcers can achieve robust closure when treated with therapies designed to actively restore regenerative multicellular function rather than relying solely on repetitive palliative care. By doubling 12-week healing rates and substantially curtailing index ulcer infections, osteomyelitis, and amputations, ACMU offers significant clinical benefits and major cost savings potential for healthcare systems managing diabetic wound complications. As wound care transitions toward value-based reimbursement and limb-preservation priorities, the COVER DFUS II trial delivers definitive Phase 3 evidence supporting the early integration of autologous biologics into standard clinical treatment pathways.
About SAWC Fall
The Symposium on Advanced Wound Care (SAWC) Fall brings the multidisciplinary wound care team together each year in Las Vegas. Held since 2009, SAWC Fall is part of HMP Global’s flagship wound care franchise, which has convened the field since 1988. The 2026 meeting, October 15–18, draws physicians, surgeons, nurses, advanced practice providers, podiatrists, physical therapists, dietitians and researchers from all 50 states and 20 countries. The program pairs the latest evidence with hands-on workshops and case-based discussion on the developments reshaping the field, from AI-driven diagnostics and advanced wound imaging to biologic therapies, mobile care delivery and vascular approaches to limb salvage, while 139 exhibiting companies bring new technologies to the exhibit hall. Learn more at hmpglobalevents.com/sawcfall.
About HMP Global
HMP Global is the trusted leader in healthcare events, education and omnichannel engagement, with a mission to improve patient care by bringing the healthcare community together. For more than 40 years, the company has built trusted brands that healthcare professionals rely on throughout their careers, including Psych Congress, the nation’s leading conference on practical psychopharmacology; the Symposium on Advanced Wound Care (SAWC), the world’s largest wound care meeting; EMS World Expo; NEI; LINC; and Advances in IBD. Today, HMP Global’s portfolio includes 27 brands and 83 events that connect more than 2 million healthcare professionals with more than 6,000 leading experts through live experiences, accredited education, year-round engagement through HMP Collective, and first-party clinician intelligence powered by Viia, creating one of the largest healthcare engagement ecosystems. Learn more at hmpglobal.com or follow the company on LinkedIn.
