Expert Roundtable Recommendations on Wound-Bed Optimization in Difficult-to-Heal Wounds: Clinical Positioning of ON101 From a U.S. Multidisciplinary Roundtable

Vollständiger Abstract

Worum geht es in dieser Arbeit?

Diabetic foot ulcers (DFUs) remain a major clinical and economic challenge and may persist within a dysregulated wound microenvironment characterized by persistent inflammation, impaired cellular signaling, microbial biofilm burden, and failure to progress through normal healing pathways. ON101 is a provider- directed topical wound-bed optimization matrix developed to support progression toward closure in difficult-to-heal DFUs. To review the available evidence and develop structured expert roundtable recommendations regarding the role of ON101 as an adjunctive wound-bed optimization approach for difficult-to-heal DFUs. Potential applications beyond DFUs were considered separately as emerging research contexts. Discussion focused on patient selection, treatment timing, integration with standard care, administration, implementation, economic considerations, and research priorities. Methods: A multidisciplinary structured expert roundtable was convened in April 2026 in Charlotte, North Carolina, involving 11 panelists, including 10 clinical experts and one wound-care research statistician and healthcare/research executive, representing wound care, surgery, podiatry, and related clinical specialties. Panel members reviewed preclinical, clinical, real-world, health-economic, regulatory, and emerging evidence and discussed key questions regarding integration of ON101 into wound management. Draft statements were developed from discussion themes and areas of broad agreement and reviewed by participants. No formal voting or prespecified agreement threshold was used, and the recommendations should not be interpreted as formal clinical practice guidelines. Results: The panel identified difficult-to-heal wounds characterized by persistent inflammation, biofilm burden, delayed closure progression, and wound microenvironment dysfunction as clinical features of interest for ON101 consideration, while recognizing that predictors of differential treatment response have not been established. Emphasis was placed on difficult-to-heal DFUs, where the strongest evidence currently exists. In physician-directed DFU care, early wound-area reduction at four weeks may serve as a prognostic reassessment marker to identify wounds requiring continued optimization or escalation; it does not establish the optimal timing of ON101 initiation. Preliminary U.S. real-world evidence reported greater early wound-area reduction, shorter time to complete closure and lower direct cost per wound with ON101 compared with matched standard-care controls; these findings are hypothesis-generating. The panel conditionally supported consideration of ON101 during active wound-bed optimization, although optimal timing has not been prospectively established. Roundtable recommendations emphasized that ON101 should be integrated with established standards of care, including etiology-appropriate wound-bed preparation, infection and vascular management, offloading or compression as indicated, and systemic optimization. While the strongest evidence currently exists for diabetic foot ulcers, applications in radiation-associated wounds, pressure injuries, venous leg ulcers, post-surgical wounds, and other difficult-to-heal wound types were considered emerging or research-only applications requiring prospective evaluation. Limitations: The recommendations reflect a structured expert roundtable informed by available evidence and clinical experience rather than formal evidence-based guidelines or standards of care. Evidence is strongest in DFUs; evidence in other wound types remains limited or preliminary. Conclusions: The panel concluded that ON101 may be considered as an adjunct to comprehensive wound care, particularly for difficult-to-heal DFUs, during active wound-bed optimization. Priority outcomes for future evaluation include complete closure, time to closure, early wound-area reduction, subsequent interventions, healthcare encounters, and total cost of care. Further research should address comparative effectiveness, patient selection, dosing, biomarkers, implementation, and health-economic outcomes, particularly beyond DFUs.