title: Clinical interventions for venous leg ulcers: Proposals to improve the quality of clinical leg ulcer research.
abstract: The present status of clinical leg ulcer healing research was reviewed by 25 experts over 2 days on September 28 and 29, 2015. Multiple clinical effectiveness reviews were presented suggesting that published clinical wound healing research often does not meet present (2015) evidence based standards. Specific areas requiring remediation were highlighted and approaches to overcoming existing challenges were proposed. Participants using anonymous voting technology developed an action plan to resolve perceived deficiencies. Statements were accepted if 75% of participants agreed. Older patients with a high frequency of comorbid conditions posed particular difficulties in designing clinical research protocols and better diagnostic categorization is necessary A standardized model template for collecting information about diagnosis and evaluation of the effect of interventions on healing of all types of leg ulcers was considered a high priority. Such a model template could be modified depending on the specific etiology of the leg ulcers. Generally agreed on quantifiable standards to establish degree of morbidity was considered a high priority. There was universal agreement that sources of funding and conflicts of interest needed to be disclosed in presentations and all publications. All clinical research studies should be registered with appropriate authorities. There was substantial enthusiasm for a clinical research network with quality standards for membership and an advisory research core available to investigators. Such a network should be funded and actively managed to insure long-term viability. The governance of such an entity needs to be established by the wound care community. The present trend to integrate patients into the clinical research process was endorsed and there was enthusiasm to develop patient advocacy for wound healing research.
authors.affiliation: Professor of Dermatology and Medicine Johns Hopkins University School of Medicine, The Johns Hopkins Wound Center, Johns Hopkins Bayview Medical Center Baltimore, Maryland. glazaru1@gmail.com.
authors.forename: Gerald S
authors.initials: GS
authors.lastname: Lazarus
authors.affiliation: Chairman and Harvey Blank Professor, Department of Dermatology and Cutaneous Surgery, Professor of Epidemiology and Public Health, University of Miami, Miller School of Medicine, Miami, Florida.
authors.forename: Robert S
authors.initials: RS
authors.lastname: Kirsner
authors.affiliation: Professor of Medicine, Johns Hopkins University School of Medicine, Johns Hopkins Bayview, Medical Center, and Chief of Infectious Disease, Johns Hopkins Bayview, Medical Center Baltimore, Maryland.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Zenilman
authors.affiliation: Assistant Professor of Nursing, University of Maryland School of Nursing, Baltimore, Maryland.
authors.forename: M Frances
authors.initials: MF
authors.lastname: Valle
authors.affiliation: Professor of Dermatology and Epidemiology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania.
authors.forename: David J
authors.initials: DJ
authors.lastname: Margolis
authors.affiliation: Head of the School of Nursings, Midwifery and Social Work, University of Manchester, Manchester, United Kingdom.
authors.forename: Nicky
authors.initials: N
authors.lastname: Cullum
authors.affiliation: Professor of Orthopedic Surgery, Brown University (clinical), President, Association for the Advancement of Wound Care, Senior Medical Director Wound Healing, Novartis Institute for Bio-Medical Research, New Indications Discovery Unit, Providence, Rhode Island.
authors.forename: Vickie R
authors.initials: VR
authors.lastname: Driver
authors.affiliation: President, Wound Recovery and Hyperbaric Medicine Center Kent Hospital, Warwick, Rhode Island.
authors.forename: Lisa
authors.initials: L
authors.lastname: Gould
authors.affiliation: Founder and President, The Lindsay Leg Club Foundation, Suffolk, United Kingdom.
authors.forename: Ellie
authors.initials: E
authors.lastname: Lindsay
authors.affiliation: Founder and President, Center for Medical Technology Programs, Baltimore, Maryland.
authors.forename: Sean
authors.initials: S
authors.lastname: Tunis
authors.affiliation: Professor and Chief, Division of Vascular Surgery, University of North Carolina School of Medicine, Chapel Hill, North Carolina.
authors.forename: William
authors.initials: W
authors.lastname: Marston
authors.affiliation: Johns Hopkins Hospital, Director of the Johns Hopkins University Evidence-based Practice Center, Baltimore, Maryland.
authors.forename: Eric
authors.initials: E
authors.lastname: Bass
authors.affiliation: Director, Clinical Professor of Surgery, Wound Healing Research, University of Illinois, Chicago, Illinois.
authors.forename: William
authors.initials: W
authors.lastname: Ennis
authors.affiliation: Professor of Pathology and Senior Research Career Scientist, Departments of Pathology, Microbiology and Immunology, Vanderbilt University Nashville, Tennessee.
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Davidson
authors.affiliation: HMP Communications, Group Publisher, Wound Care Division, Malvern, Pennsylvania.
authors.forename: Jeremy
authors.initials: J
authors.lastname: Bowden