The FDA and designing clinical trials for chronic cutaneous ulcers
Abstract
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.
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Clinical trial design in chronic wounds faces multiple challenges.
“Clinical trial design in the area of chronic wounds faces multiple challenges (160).”
From Wound repair and regeneration: Mechanisms, signaling, and translation (2014) · cites this paper as [160]
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- Authors
- Maderal, A. D., Vivas, A. C., Eaglstein, W. H., & Kirsner, R. S.
- Affiliations
- University of Miami (US)
- Corresponding author
- Kirsner, Robert S.
- Venue
- Seminars in Cell & Developmental Biology
- Publisher
- Elsevier BV
- Published
- 2012-12
- Volume
- 23
- Issue
- 9
- Pages
- 993-999
- ISSN
- 1084-9521 (ISSN-L)
- OpenAlex
- W2047254124
- Cited by
- 41
- References
- 34
- Citations by year
- 2026: 1 · 2025: 3 · 2024: 6 · 2023: 1 · 2022: 9 · 2021: 2 · 2020: 2 · 2019: 3 · 2018: 4 · 2016: 3 · 2015: 2 · 2014: 3 · 2013: 1
- FWCI
- 0.24
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Seminars in Cell and Developmental Biology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Rehabilitation › Wound Healing and Treatments
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetic Foot Ulcer Assessment and Management
- Keywords
- chronic wounds, chronic cutaneous ulcers, clinical trial design, FDA drug approval, diabetic foot ulcer, venous leg ulcers, drug development
- MeSH terms
- Chronic Disease, Clinical Trials as Topic, Humans, Research Design, Skin Ulcer, United States, United States Food and Drug Administration, Varicose Ulcer, Wound Healing, Drugs, Investigational, Treatment Outcome, Drug Approval, Diabetic Foot, Patient Selection
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