Principal reported finding
What the publication reports
The Wound Care Collaborative Community proposes modernizing the 2006 FDA guidance with standardized preclinical reporting, digital wound assessment, biomarkers, innovative trial designs, and validated alternative and patient-reported endpoints while retaining complete closure as the principal endpoint.
Study context
Evidence should be read with its design.
- Study type
- Field leadership / trial-design perspective
- Publication date
- Journal
- Wounds 38(6):155–165
Interpretation
This field-leadership perspective contributes to the discussion of wound-study endpoints and trial design; it is not product-efficacy evidence.