RECAP: FDA’s Patient-Focused Drug Development Meeting On Nonhealing Chronic Wounds

On August 25th, the Wound and Hyperbaric Association had the opportunity to attend 𝗙𝗗𝗔'𝘀 𝗣𝗮𝘁𝗶𝗲𝗻𝘁-𝗙𝗼𝗰𝘂𝘀𝗲𝗱 𝗗𝗿𝘂𝗴 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 𝗺𝗲𝗲𝘁𝗶𝗻𝗴 𝗼𝗻 𝗡𝗼𝗻𝗵𝗲𝗮𝗹𝗶𝗻𝗴 𝗖𝗵𝗿𝗼𝗻𝗶𝗰 𝗪𝗼𝘂𝗻𝗱𝘀, an all-day public session that brought together patients, caregivers, and FDA staff to discuss the real-world burden of living with hard-to-heal wounds.

Key Takeaways:

Patients led the conversation. Roughly 30 patients and caregivers shared deeply personal stories throughout the day, and industry and providers were asked to listen. Many of these stories were emotional and powerful, highlighting wounds that persisted for years across a wide range of underlying conditions, from diabetes to cancer radiation to sickle cell disease.

Wound healing means more than wound closure. A consistent theme was that clinical success can't be measured by size or closure alone. Patients emphasized pain, sleep, mobility, independence, ability to work, and quality of life as equally important outcomes, input FDA noted could shape future trial design and endpoints.

Home-based care matters. Multiple patients and the Wound Care Collaborative Community highlighted the critical need for mobile and in-home wound care, especially for those who are bedridden or face barriers to frequent travel.

Chronic wounds deserve to be treated as a disease. There was meaningful discussion around shifting how the FDA and the broader medical community categorize chronic nonhealing wounds: not merely as a complication of another condition, but as a disease in their own right.

FDA will post the meeting transcript and summary in the coming weeks.

Written comments can be submitted to the public docket through October 26.