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Updated: Aug 12, 2026
A Simplified Technique for Producing an Ischemic Wound Model
Published on: May 2, 2012
Evidence supporting wound care end points relevant to clinical practice and patients' lives. Part 2. Literature
Vickie R Driver1,2, Lisa J Gould1,3, Peggy Dotson4
1Brown University School of Medicine, Providence, Rhode Island.
Abstract:
Patients with wounds bear significant clinical, personal, and economic burdens yet complete wound healing is the only United States Food and Drug Administration (FDA) recognized primary clinical trial end point. The overall goal of this project is to work with FDA to expand the list of acceptable primary end points, recognizing that new and innovative treatments, devices, and drugs may not have complete healing as the focus. Part 1 of the project surveyed 628 wound care experts who identified and content-validated 15 end points most relevant to clinical practice and benefitting patients' lives as primary outcomes in clinical trials. Part 2 is focused on critical appraisal of the evidence in the wound care literature supporting FDA criteria to qualify these 15 end points as primary end points in clinical trials. Further research involved systematic review of the literature regarding the most promising end points. Forty volunteer, interdisciplinary, wound healing experts in fields related to the end points compiled evidence from systematic MEDLINE searches and society databases supporting the FDA criteria of reliability, clinical construct validity, capacity to detect concurrent or longitudinal change, and responder analysis. The search revealed 485 references involving over 462,000 subjects supporting FDA-required parameters for all 15 end points More than 50 references supported FDA-required parameters qualifying the following outcomes for use in clinical trials supporting interventions for FDA clearance: Pain reduction, Physical function and ambulation, Infection reduction, Time to heal, and Percent wound area reduction in 4-8 weeks. Among these, only Time to heal is currently recognized by the FDA as a primary wound outcome in clinical trials. These results suggest that wound science is already serving patients and professionals by improving these content-validated outcomes that merit regulatory consideration.
Insights
The United States Food and Drug Administration (FDA) should expand primary clinical trial endpoints beyond complete wound healing. Evidence supports using outcomes like pain reduction and infection control for wound healing innovations.
Area of Science:
- Wound healing research
- Clinical trial methodology
- Regulatory science
Background:
- Complete wound healing is the sole primary endpoint recognized by the United States Food and Drug Administration (FDA) for clinical trials.
- Patients with wounds face substantial clinical, personal, and economic burdens.
- Innovative treatments may not prioritize complete healing as their primary focus.
Purpose of the Study:
- To collaborate with the FDA to broaden the range of acceptable primary endpoints for wound healing clinical trials.
- To identify and validate alternative endpoints that reflect clinical practice and patient benefit.
- To critically appraise existing literature supporting these endpoints for regulatory consideration.
Main Methods:
- Surveyed 628 wound care experts to identify and validate 15 relevant clinical trial endpoints.
- Conducted a systematic literature review of 485 references (over 462,000 subjects) to assess evidence supporting FDA criteria.
- Engaged 40 interdisciplinary experts to evaluate endpoints based on reliability, validity, and responsiveness.
Main Results:
- Fifteen endpoints were identified and validated by experts as relevant to clinical practice.
- Evidence supporting FDA criteria was found for all 15 endpoints.
- Over 50 references supported the use of pain reduction, physical function, infection reduction, time to heal, and percent wound area reduction as primary outcomes.
Conclusions:
- Current wound science supports multiple validated outcomes beyond complete healing for clinical trials.
- Pain reduction, physical function, infection reduction, time to heal, and percent wound area reduction meet FDA criteria for primary endpoints.
- These outcomes merit regulatory consideration to facilitate the approval of novel wound care interventions.
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