Defining success in clinical trials of diabetic foot wounds: the Los Angeles DFCon consensus.
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.
Armstrong
David G
DG
Southern Arizona Limb Salvage Alliance, University of Arizona College of Medicine, Tucson, 85701, AZ, USA. armstrong@usa.net
Boulton
Andrew J M
AJ
Andros
George
G
Attinger
Christopher
C
Eisenbud
David
D
Lavery
Lawrence A
LA
Lipsky
Benjamin A
BA
Mills
Joseph L
JL
Sibbald
Gary
G
Smith
Adrianne P
AP
Wukich
Dane
D
Margolis
David J
DJ
D002986:Clinical Trials as Topic; D003257:Consumer Product Safety; D017719:Diabetic Foot / Q000628:therapy*; D017408:Guidelines as Topic; D006801:Humans; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration; D014945:Wound Healing / Q000502:physiology*