Special to OWM: Seeking an Evidence Base for Clinical Interventions for Venous Leg Ulcers

Although 1% to 2% of the population 65+ years has a venous leg ulcer (it is one of the most common chronic wounds) and despite a plethora of research, several recently published reviews of the venous ulcer literature published by the Agency for Health Care Research and Quality (AHRQ) and the Centers for Medicare and Medicaid (CMS) reveal a startling lack of quality evidence to inform practice. In response, the Wound Healing Coalition Foundation and HMP Communications, with financial support from pharmaceutical companies, device manufacturers, and wound management companies, convened a 2-day meeting of experts In September 2015 to explore the present status of clinical research on leg ulcer healing. The goals of this event were to analyze flaws uncovered in relevant published research, determine ways to address gaps in research/practice, and develop an action plan to improve clinical leg ulcer research.

The consensus meeting included key opinion leaders from the Association of Advanced Wound Care, the Symposium for Advanced Wound Care, the Wound Healing Society, the American Venous Forum, the Society for Vascular Surgery, the American College of Wound Healing, the Wound Ostomy Continence Nurses Association, the American Society of Physical Therapy, the United States Food and Drug Administration (FDA), the CMS, pharmaceutical manufacturers, wound care management companies, and distinguished clinical wound care researchers. 

The outcomes of the consensus meeting have been published (Lazarus GS, Kirsner RS, Zenilman J, Valle MF, Margolis DJ, Cullum N, Driver VR, Gould L, Lindsay E, Tunis S, Marston W, Bass E, Ennis W, Davidson J, Bowden J. Clinical interventions for venous leg ulcers: proposals to improve the quality of clinical leg ulcer research. Wound Repair Regen. 2016; in press).

During the initial portion of the meeting, participants discussed and analyzed aspects and problems of research, including study design (and subsequent level of evidence), efficacy and effectiveness, discrepancies in definitions, ill-described inclusion/exclusion criteria, and internal and external validity. Additional concerns specific to venous ulcer research included imprecision of wound measurements, lack of consistency in defining healing rates and clinical endpoints, overlooked metrics regarding pain and morbidity, methodological issues, and the challenges of conducting research sensitive to and inclusive of patients with venous ulcers. 

The remainder of the meeting focused on the development of an action plan. After extensive debate, a minimum 75% majority for each item determined:

1. Present diagnostic and assessment tools are insufficient for clinical wound care investigation;
2. Parameters are inadequate to segregate wounds into common clinical types in the 65+ population with multiple comorbidities;
3. Clinical trials in wound care would benefit from improved diagnostic tools;
4. A standard data template for collecting clinical research information for the major types of leg ulcers, modified for particular wound types, is needed;
5. The wound healing community should adopt and if necessary validate existing instruments that assess factors such as quality of life and mobility for patients with leg ulcers to assess changes in morbidity;
6. Researchers should define clinical research approaches for surgical, device, and procedural interventions for chronic leg ulcers;
7. The wound healing community should 1) require the funding source and conflicts of interest to be reported for presentations and publications on wound healing; 2) require prospective registration of trials on national or international registries; and 3) attempt to improve clinical research in wound healing research generally with the first focus on improving venous leg ulcer research;
8. A wound care clinical trials network should be organized that ensures quality control within and between centers;
9. A research core group should be created to provide guidance and/or develop model guidelines for wound healing research generally and leg ulcer research specifically using existing standards. This group does not need to recommend specific competencies for persons conducting clinical wound healing evaluation research;
10. There should be site requirements to be part of a funded and managed clinical trial network (no current organization or consortium exists to house such a center, but one could be created);
11. Patients could play a role in clinical research protocol development, implication of study results, and commenting on plain language summaries and reviews; and
12. A patient advocacy network should be developed that educates patients about the research process, types of protocols and new developments.

OWM applauds these efforts. 

This article was not subject to the Ostomy Wound Management peer-review process