The FDA and designing clinical trials for chronic cutaneous ulcers

Andrea D. Maderal, Alejandra C. Vivas, William H. Eaglstein, Robert S. Kirsner

Research output: Contribution to journalReview articlepeer-review

16 Scopus citations


Treatment of chronic wounds can present a challenge, with many patients remaining refractory to available advanced therapies. As such, there is a strong need for the development of new products. Unfortunately, despite this demand, few new wound-related drugs have been approved over the past decade. This is in part due to unsuccessful clinical trials and subsequent lack of Food and Drug Administration (FDA) approval. In this article, we discuss the FDA approval process, how it relates to chronic wound trials, common issues that arise, and how best to manage them. Additionally, problems encountered specific to diabetic foot ulcers (DFU) and venous leg ulcers (VLU) are addressed. Careful construction of a clinical trial is necessary in order to achieve the best possible efficacy outcomes and thereby, gain FDA approval. How to design an optimal trial is outlined.

Original languageEnglish (US)
Pages (from-to)993-999
Number of pages7
JournalSeminars in Cell and Developmental Biology
Issue number9
StatePublished - Dec 2012


  • Chronic wound
  • Clinical trial
  • Diabetic foot ulcer
  • Food and Drug Administration (FDA)
  • Venous leg ulcer

ASJC Scopus subject areas

  • Developmental Biology
  • Cell Biology


Dive into the research topics of 'The FDA and designing clinical trials for chronic cutaneous ulcers'. Together they form a unique fingerprint.

Cite this