Open AccessDefining success in clinical trials of diabetic foot wounds: the Los Angeles DFCon consensus
Author(s) -
Armstrong David G,
Boulton Andrew JM,
Andros George,
Attinger Christopher,
Eisenbud David,
Lavery Lawrence A,
Lipsky Benjamin A,
Mills Joseph L,
Sibbald Gary,
Smith Adrianne P,
Wukich Dane,
Margolis David J
Publication year - 2009
Publication title -
international wound journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.867
H-Index - 63
eISSN - 1742-481X
pISSN - 1742-4801
DOI - 10.1111/j.1742-481x.2009.00598.x
Subject(s) - medicine , diabetic foot , clinical trial , foot (prosody) , diabetes mellitus , surgery , intensive care medicine , endocrinology , linguistics , philosophy
Regulatory requirements for new products should be guided by clinical trials that protect the public by a thorough evaluation of safety and efficacy, while not creating unnecessary barriers to their development and ultimate approval. While healing a wound is the ultimate goal of treating an individual with a diabetic foot ulcer, achieving this goal is physiologically complex requiring the initiation and interaction of many events and therefore unlikely to be achieved by one compound. We believe that developing new, more meaningful, study outcomes or end points in wound care trials would both aid in determining the true efficacy of wound management modalities and facilitate the product development cycle. The primary guidance from the US Food and Drug Administration to industry in this field was published in 2006. This document, while helpful and largely in concert with current knowledge of wound healing, needs to be substantially improved. We therefore convened an interdisciplinary task force comprising experts in various aspects of wound care to attempt to achieve consensus in defining primary outcomes and potential secondary endpoints for various classes of wound‐healing modalities.