Proposed addendum to the 2006 US Food and Drug Administration guidance on chronic cutaneous ulcers and burn wounds: recommendations from the Wound Care Collaborative Community.

Abstract

The Wound Care Collaborative Community (WCCC) presents this proposed addendum to the 2006 US Food and Drug Administration (FDA) guidance for industry on chronic cutaneous ulcers and burn wounds, with this addendum reflecting nearly 2 decades of scientific and clinical progress. Key gaps in the original guidance have emerged with advances such as the Wound Reporting in Animal and Human Preclinical Studies (WRAHPS) reporting standards and the FDA Biomarker Qualification Program. This proposed addendum updates preclinical recommendations by emphasizing standardized bioassays for biologics, improved animal model selection using WRAHPS criteria, and acknowledgment that animal studies primarily assess safety rather than predict clinical efficacy. Clinical study design recommendations incorporate digital wound assessment technologies; standardized photographic documentation; expanded biomarker use; and innovative umbrella, basket, and platform trial designs to better address biological heterogeneity in chronic wounds. While reaffirming complete wound closure as the most clinically meaningful end point, the addendum also supports the development of validated alternative end points, including patient-reported outcomes. Additional updates include biofilm detection strategies, point of care diagnostic tools, and recognition of differences between clinical trial populations and real world patients. These evidence based recommendations aim to accelerate development of safe and effective wound care products while ensuring alignment with modern regulatory standards.