Identification and content validation of wound therapy clinical endpoints relevant to clinical practice and patient values for FDA approval. Part 1. Survey of the wound care community

Abstract

Wounds that exhibit delayed healing add extraordinary clinical, economic, and personal burdens to patients, as well as to increasing financial costs to health systems. New interventions designed to ease such burdens for patients with cancer, renal, or ophthalmologic conditions are often cleared for approval by the U.S. Food and Drug Administration (FDA) using multiple endpoints but the requirement of complete healing as a primary endpoint for wound products impedes FDA clearance of interventions that can provide other clinical or patient-centered benefits for persons with wounds. A multidisciplinary group of wound experts undertook an initiative, in collaboration with the FDA, to identify and content validate supporting FDA criteria for qualifying wound endpoints relevant to clinical practice (CP) and patient-centered outcomes (PCO) as primary outcomes in clinical trials. As part of the initiative, a research study was conducted involving 628 multidisciplinary expert wound clinicians and researchers from 4 different groups: the interdisciplinary core advisory team; attendees of the Spring 2015 Symposium on Advanced Wound Care (SAWC); clinicians employed by a national network of specialty clinics focused on comprehensive wound care; and Association for the Advancement of Wound Care (AAWC) and Wound Healing Society (WHS) members who had not previously completed the survey. The online survey assessed 28 literature-based wound care endpoints for their relevance and importance to clinical practice and clinical research. Fifteen of the endpoints were evaluated for their relevance to improving quality of life. Twenty-two endpoints had content validity indexes (CVI) ≥ 0.75, and 15 were selected as meriting potential inclusion as additional endpoints for FDA approval of future wound care interventions. This study represents an important first step in identifying and validating new measurable wound care endpoints for clinical research and practice and for regulatory evaluation.

The role of the microbiome in nonhealing diabetic wounds

“…However, complete wound closure is not always achievable for patients living with a chronic wound. Other outcomes, such as limb salvage, infection reduction, and improved quality of life, are more important to these patients . Furthermore, wound closure is not the sole metric to evaluate eradication of infection.…”

Healing Chronic Wounds: Current Challenges and Potential Solutions

“…While ideally the best wound treatment is one that closes the wound, this is not the only meaningful outcome that benefits to patients. For example, an outcome that reduces morbidity and mortality, such as a reduction in lower extremity amputations, would clearly be significant [39, 36]. …”

“…A survey of wound care clinicians assessed alternative wound outcome measurements [36]. The top endpoints supported by wound care professionals included reduced pain (currently recognized as a secondary endpoint), reduced infection (currently recognized as a secondary endpoint), percent area reduction after 4–8 weeks of care, reduced recurrence, reduced amputation, reduced economic burden, improved function and ambulation, and improved quality of life (including social isolation, depression, odor, pain, and function) [36]. This study is very encouraging as it initiates the dialogue between the government and the wound healing community including patients, wound care providers, wound healing related societies, industry and insurance companies.…”

“…In turn, this allows for combined therapeutic approaches and a higher level of customization. As we mentioned above, there is an effort currently being undertaken by the wound research community and the FDA to establish other therapeutic targets to wound healing [36]. This would allow significantly more treatment options to be approved, and would drastically improve quality of life.…”

Comparative cost and clinical effectiveness of clostridial collagenase ointment for chronic dermal ulcers

“…Consequently, there are no currently FDA-approved end points that might be more suitable for short-term outcomes, such as wound granulation percentage at 4 weeks after first or last CCO application. A group of wound care researchers is currently working with the FDA to approve new clinical-reported outcome and patient-reported outcome end points that may be more suitable end points for clinical trials involving CCO [56].…”