Designing clinical trials for wound care therapies is uniquely challenging. From variable healing rates to inconsistent clinical practices, even well-funded studies can falter without a solid foundation. Whether you're developing advanced wound dressings, biologics, or regenerative therapies, avoiding common trial design pitfalls is essential for regulatory success and market impact.

In this blog, we explore the top five trial design mistakes that can derail wound care studies—and how to prevent them.

1. Inconsistent Standard of Care

Why it matters: Wound care practices vary widely across sites and regions. Without a clearly defined and enforced standard of care, trial results can become unreliable or non-reproducible.

Solution: Establish a uniform treatment protocol across all sites and ensure adherence through training and monitoring. This reduces variability and strengthens your data integrity.

2. Poor Endpoint Selection

Why it matters: Endpoints like “complete wound closure” or “time to healing” must be clinically meaningful, measurable, and acceptable to regulators. Poorly chosen endpoints can lead to inconclusive results or FDA rejection.

Solution: Use validated, objective endpoints aligned with FDA guidance and patient outcomes. Consider incorporating digital wound measurement tools to improve accuracy.

3. Lack of Blinding Strategies

Why it matters: Blinding is difficult in wound care trials, especially when interventions are visibly different. But without it, bias can skew results.

Solution: Implement partial blinding where full blinding isn’t feasible. Use independent wound assessors or digital imaging reviewed by blinded adjudicators.

4. Underpowered Sample Sizes

Why it matters: Too few participants can lead to statistically insignificant results, even if the treatment is effective.

Solution: Conduct a robust power analysis during trial planning. Account for dropout rates and variability in wound healing to ensure your study is adequately powered.

5. Inadequate Site Training

Why it matters: Even the best protocol can fail if site staff aren’t properly trained. Inconsistent wound assessments and protocol deviations can compromise your data.

Solution: Invest in comprehensive site training and ongoing support. Use centralized training modules and certification programs to ensure consistency across all trial locations.

Build Better Trials from the Start

Avoiding these pitfalls can dramatically improve your trial’s success rate, reduce delays, and increase your chances of regulatory approval.

Trial Design Checklist – Wound Care Clinical Trials

Use this checklist to validate your trial design before launch:

Protocol & Endpoints

• Are endpoints clinically meaningful and measurable?
• Are endpoints aligned with FDA guidance?
• Have you included secondary endpoints for added insight?

Standard of Care

• Is a consistent standard of care defined across all sites?
• Are treatment protocols clearly documented and enforced?

Blinding & Bias Control

• Is blinding feasible? If not, are alternative bias controls in place?
• Are independent or blinded assessors used?

Sample Size & Power

• Has a power analysis been conducted?
• Are dropout rates and healing variability accounted for?

Site Training & Monitoring

• Have all sites received standardized training?
• Are there tools in place for ongoing compliance monitoring?