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Clinical interventions for venous leg ulcers: Proposals to improve the quality of clinical leg ulcer research |
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| Authors: | Gerald S. Lazarus MD Robert S. Kirsner MD PhD Jonathan Zenilman MD M. Frances Valle DNP MS David J. Margolis MD PhD Nicky Cullum PhD RN DBE Vickie R. Driver DPM MS FACFAS Lisa Gould MD PhD Ellie Lindsay OBE BSc RN DN CPT DipHE Sean Tunis MD William Marston MD Eric Bass MD MPH William Ennis DO MBA FACOS Jeffrey Davidson PhD Jeremy Bowden VP |
| Affiliation: | 1. Professor of Dermatology and Medicine Johns Hopkins University School of Medicine, The Johns Hopkins Wound Center, Johns Hopkins Bayview Medical Center Baltimore, Maryland;2. Chairman and Harvey Blank Professor, Department of Dermatology and Cutaneous Surgery, Professor of Epidemiology and Public HealthUniversity of Miami, Miller School of Medicine, Miami, Florida;3. 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;4. Assistant Professor of Nursing, University of Maryland School of Nursing, Baltimore, Maryland;5. Professor of Dermatology and Epidemiology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania;6. Head of the School of Nursings, Midwifery and Social Work, University of Manchester, Manchester, United Kingdom;7. Professor of Orthopedic Surgery, Brown University (clinical), President, Association for the Advancement of Wound Care, Senior Medical Director Wound HealingNovartis Institute for Bio‐Medical Research, New Indications Discovery Unit, Providence, Rhode Island;8. President, Wound Recovery and Hyperbaric Medicine Center Kent Hospital, Warwick, Rhode Island;9. Founder and President, The Lindsay Leg Club Foundation, Suffolk, United Kingdom;10. Founder and President, Center for Medical Technology Programs, Baltimore, Maryland;11. Professor and Chief, Division of Vascular SurgeryUniversity of North Carolina School of Medicine, Chapel Hill, North Carolina;12. Johns Hopkins HospitalDirector of the Johns Hopkins University Evidence‐based Practice Center, Baltimore, Maryland;13. Director, Clinical Professor of SurgeryWound Healing Research, University of Illinois, Chicago, Illinois;14. Professor of Pathology and Senior Research Career Scientist, Departments of Pathology, Microbiology and ImmunologyVanderbilt University Nashville, Tennessee;15. HMP Communications, Group Publisher, Wound Care Division, Malvern, Pennsylvania |
| 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. |
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