The FDA and designing clinical trials for chronic cutaneous ulcers

Semin Cell Dev Biol. 2012 Dec;23(9):993-9. doi: 10.1016/j.semcdb.2012.09.014. Epub 2012 Oct 9.


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.

Publication types

  • Review

MeSH terms

  • Chronic Disease
  • Clinical Trials as Topic
  • Diabetic Foot / pathology
  • Diabetic Foot / therapy*
  • Drug Approval
  • Drugs, Investigational / pharmacology
  • Drugs, Investigational / therapeutic use*
  • Humans
  • Patient Selection
  • Research Design*
  • Skin Ulcer / pathology
  • Skin Ulcer / therapy*
  • Treatment Outcome
  • United States
  • United States Food and Drug Administration*
  • Varicose Ulcer / pathology
  • Varicose Ulcer / therapy*
  • Wound Healing / drug effects


  • Drugs, Investigational