Wound Care Collaborative Community Proposes First Comprehensive Update to FDA Guidance on Chronic Wounds in Nearly 20 Years
MALVERN, Pa. — June 18, 2026 —The Wound Care Collaborative Community (WCCC) and WOUNDS, a peer-reviewed clinical journal for the wound care field, today jointly announced the publication of a proposed addendum to the U.S. Food and Drug Administration's foundational 2006 guidance on the development of products for chronic cutaneous ulcers and burn wounds.
The article appears in WOUNDS, which is indexed in MEDLINE/PubMED and is the official journal of the Symposium on Advanced Wound Care (SAWC).
Chronic wounds affect roughly 10.5 million people in the United States, about one in six Medicare beneficiaries, and cost Medicare an estimated $22.5 billion a year, according to a 2025 analysis in Advances in Wound Care. Despite that burden, very few treatments have earned FDA approval for efficacy, and the 2006 guidance that governs how new drugs, biologics, and devices are studied has remained largely unchanged even as the underlying science has advanced. The WCCC addendum is the field's first comprehensive effort to update that framework for current science and clinical practice.
"For almost twenty years, our field has been developing products against a framework that predates much of the science we rely on today," said Windy Cole, DPM, lead author and a wound care researcher at the College of Podiatric Medicine, Kent State University. "The aim of this addendum is to bring the original guidance up to date, so that safe and effective therapies can reach patients sooner and with stronger evidence behind them."
The proposed addendum addresses several gaps in the original guidance:
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Preclinical standards: a stronger emphasis on standardized bioassays for biologics and better animal model selection, with explicit acknowledgment that animal studies assess safety more than they predict clinical efficacy.
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Clinical trial design: the use of digital wound assessment, standardized photographic documentation, wider use of biomarkers, and newer umbrella, basket, and platform trial designs suited to the variability of chronic wounds.
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End points: complete wound closure is reaffirmed as the most clinically meaningful outcome, alongside support for validated alternatives such as patient-reported outcomes.
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Real-world relevance: biofilm detection, point-of-care diagnostics, and recognition of the differences between clinical trial populations and the patients clinicians see every day.
The WCCC is an FDA Collaborative Community, a continuing forum in which private- and public-sector members, including the FDA, work together on shared challenges in medical product development. The addendum reflects that model, bringing together clinicians, scientists, industry leaders, and regulatory-science expertise around the shared goal of improving outcomes for the millions of patients living with chronic wounds.
""The need for innovative wound care treatments has been clear for more than a decade, but until the WCCC, there was no specialized group to take on a project of this scope," said Vickie R. Driver, DPM, MS, FACFAS, founder and President and Chair of the Board of Directors of the Wound Care Collaborative Community and Professor in the School of Medicine at Washington State University. "The strength and rigor of this work are a testament to a multidisciplinary, multi-industry team of clinicians, academics, and industry professionals, and I am deeply proud of the colleagues who volunteered their time and expertise to make it a reality. We did this for patients seeking new and advanced treatments, and to improve access to the options already in our clinics. Change happens only when the need is clearly understood and a collaborative team executes a well-defined strategy."
WOUNDS is published by HMP Global, which also supports the WCCC through year-round programming, including the annual WCCC Driving Innovation Summit held during SAWC Spring.
"This is contemporary comment and guidance from the wound care field to help the FDA provide a more comprehensive and consensus driven approach to the methodology we use in developing new products to help patients close wounds. Given that the previous document is 20 years old, this is a wonderful conversation to start, and the WCCC is positioned well to collaborate with the FDA on this important document,” said John C. Lantis II, MD, FACS, Editor-in-Chief of WOUNDS and Site-Chief of Surgery at Mount Sinai West Hospital. "It represents the kind of careful, consensus-driven work that can shape how chronic wound therapies are developed for years to come."
The full article, "Proposed Addendum to the 2006 US Food and Drug Administration Guidance on Chronic Cutaneous Ulcers and Burn Wounds: Recommendations from the Wound Care Collaborative Community," is available in WOUNDS (doi:10.25270/wnds/25132) at woundsresearch.com.
The Wound Care Collaborative Community (WCCC) is an FDA Collaborative Community working in the pre-competitive space to help ensure that patients and clinicians have access to safe, effective, and high-quality devices and drugs for chronic wounds. It brings together clinicians, researchers, industry, and regulatory stakeholders to identify the methods, tools, and clinical evidence needed to improve how wound care products are evaluated, with the aim of speeding patient access to innovative treatments while reducing cost and time to market.
About WOUNDS
WOUNDS is a widely read peer-reviewed journal focused on wound care and wound research, indexed in MEDLINE/PubMED and the official journal of the Symposium on Advanced Wound Care (SAWC) Spring and Fall. Published by HMP Global, the journal covers tissue repair and regeneration, the biology and biochemistry of wound healing, and the clinical management of various wound etiologies.
About HMP Global
HMP Global is the omnichannel market leader in healthcare events, education, and insight, with a mission to improve patient care. For 40 years, the company has built trusted brands including Psych Congress, the premier source for mental health education, and the Symposium on Advanced Wound Care (SAWC), the largest wound care meeting in the world. HMP Global partners with leading experts around the world to deliver more than 450 annual events, medical strategy, and marketing for pharmaceutical and medical device customers through HMP Collective, and pharmaceutical market insight, engaging a global community of healthcare stakeholders that includes nearly 2 million clinicians across 600 medical specialties as well as managed care, behavioral health, senior living, emergency medical, and pharmaceutical commercialization professionals. For more information, follow HMP Global on LinkedIn or visit hmpglobal.com.
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