Consensus principles for wound care research obtained using a Delphi process.

Too many wound care research studies are poorly designed, badly executed, and missing crucial data. The objective of this study is to create a series of principles for all stakeholders involved in clinical or comparative effectiveness research in wound healing. The Delphi approach was used to reach consensus, using a web-based survey for survey participants and face-to-face conferences for expert panel members. Expert panel (11 members) and 115 wound care researchers (respondents) drawn from 15 different organizations. Principles were rated for validity using 5-point Likert scales and comments. A 66% response rate was achieved in the first Delphi round from the 173 invited survey participants. The response rate for the second Delphi round was 46%. The most common wound care researcher profile was age 46-55 years, a wound care clinic setting, and >10 years' wound care research and clinical experience. Of the initial 17 principles created by the panel, only four principles were not endorsed in Delphi round 1 with another four not requiring revision. Of the 14 principles assessed by respondents in the second Delphi round, only one principle was not endorsed and it was revised; four other principles also needed revision based on the use of specific words or contextual use. Of the 19 final principles, three included detailed numbered lists. With the wide variation in design, conduct, and reporting of wound care research studies, it is hoped that these principles will improve the standard and practice of care in this field.

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.