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Chronic Venous Leg Ulcer Treatment: Future Research Needs
Future Research Needs Papers, No. 34
Investigators: Gerald Lazarus, MD, Fran Valle, DNP, MS, CRNP, Mahmoud Malas, MD, MHS, Umair Qazi, MD, MPH, Nisa Maruthur, MD, MHS, Jonathan Zenilman, MD, Chad Boult, MD, MPH, MBA, David Doggett, PhD, Oluwakemi A Fawole, MBCHB, MPH, and Eric B Bass, MD, MPH.
Author Information and AffiliationsExcerpt
Uncertainties Prompting Systematic Review:
Chronic venous leg ulcers affect between 500,000 and 2 million persons annually, and over 50 percent of leg ulcers in the United States are classified as venous ulcers. They are caused by elevated venous pressure, turbulent venous flow, and inadequate venous return that can be due to occlusion or reflux in the venous system. The Johns Hopkins University Evidence-based Practice Center performed a systematic review to determine the effectiveness and safety of advanced wound dressings, systemic antibiotics, and surgical interventions relative to either compression systems or each other among patients with chronic venous leg ulcers. We defined chronic venous leg ulcers as active, noninfected ulcers present for 6 weeks or more with evidence of pre-existing venous disease. An analytic framework was used in the systematic review to describe research gaps. Standard therapy includes aggressive compression with debridement, which heals 50 to 60 percent of venous leg ulcers. Widely used add-on interventions include wound dressings with active components (“advanced wound dressings”), local or systemic antimicrobials, and venous surgery.The comparative effectiveness and safety of these advanced wound dressings, antimicrobials and surgical procedures is unclear.
Purpose of Future Research Needs Report:
We sought to identify the evidence gaps in the systematic review, to engage a representative group of stakeholders in prioritizing the gaps, and to develop future research needs questions regarding the high-priority gaps, with some discussion of appropriate study design taking into consideration the pertinent populations, interventions, comparisons, outcome measures, timing, and setting (PICOTS).
Contents
- Addendum
- Preface
- Acknowledgments
- Limitations of Systematic Review
- Executive Summary
- Background
- Methods
- Identification of Evidence Gaps
- Engagement of Stakeholders, Researchers, and Funders
- Stakeholder Engagement for Additional Gap Identification and Prioritization
- Research Question Development and Research Design Considerations
- Ongoing Clinical Trial Searches
- Analytic Framework
- Identification of Study Design and Methodology Problems
- Results
- Discussion
- Conclusions
- References
- Abbreviations
- Appendix A Round 1 Questionnaire
- Appendix B Final Prioritization of Future Research Needs for Chronic Venous Ulcers
- Appendix C Chronic Venous Leg Ulcer Future Research Needs Stakeholder Priority Master List
- Appendix D Search Strategies for Ongoing Studies
- Appendix E Ongoing/Recently Completed Studies Related to Treatment of Chronic Venous Leg Ulcers
Addendum added January 2014
Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services1, Contract No. 290-2007-10061-I. Prepared by: Johns Hopkins University Evidence-based Practice Center, Baltimore, MD
Suggested citation:
Lazarus G, Valle F, Malas M, Qazi U, Maruthur N, Zenilman J, Boult C, Doggett D, Fawole OA, Bass EB. Chronic Venous Leg Ulcer Treatment: Future Research Needs. Future Research Needs Paper No. 34. (Prepared by Johns Hopkins University Evidence-Based Practice Center under Contract No. 290-2007-10061-I.) AHRQ Publication No. 13(14)-EHC034-EF. Rockville, MD: Agency for Healthcare Research and Quality. November 2013. Addendum added January 2014. www.effectivehealthcare.ahrq.gov/reports/final.cfm.
This report is based on research conducted by the Johns Hopkins University Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2007-10061-I). The findings and conclusions in this document are those of the author(s), who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.
The information in this report is intended to help health care researchers and funders of research make well-informed decisions in designing and funding research and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of scientific judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical research and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances.
None of the investigators have any affiliation or financial involvement that conflicts with the material presented in this report.
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