This issue is devoted to the topic of Interdisciplinary Wound Care Outcomes. Dr. Laura Bolton has done an exemplary job of assembling experts to address the topics involved in managing wound care outcomes and using these outcomes to develop evidence- based protocols in an attempt to obtain consistent, cost effective therapy for patients with chronic wounds. At the risk of sounding heretical, and incurring the wrath of many friends and colleagues, I would like to expand on the findings of Dr. Ennis and colleagues (page 286), and suggest that perhaps evidence-based protocols are not the magic bullet for which we all are searching. As Dr. Bolton notes in her Commentary, Dr. Ennis’s work has shown that interdisciplinary teams providing care using evidence-based protocols do not seem to achieve the same outcomes every time. What is the problem? We have been led to believe that following evidence-based protocols that are based on the gold standard of randomized, controlled, clinical trials should lead us to consistent, reliable outcomes.¹

       Randomized controlled trials are designed to compare two treatments in two theoretically equivalent groups of patients.² It is well-known, despite everyone’s best efforts,that there are differences between individuals in each treatment group that can affect the outcome of the therapies.^2–5 Everyone who has ever enrolled patients in a clinical trial knows that the patients who qualify for the trial are a select group who have wounds that are not too large yet not too small,well-controlled diabetes mellitus, a serum creatinine within normal range, who are able to fully cooperate with study instructions, and are able to wear an offloading device at all times—the list goes on and on. We know that this is not the “real world” of our patients. Our wound center recently participated in a diabetic foot ulcer trial. In a week, our clinic sees about 150 patients with diabetic foot ulcers, and despite intense efforts to enroll patients,we were only able to enroll 2 into the trial. The rest of the patients had ulcers too large or too small, blood sugar too high, etc. I have no problem with that approach, but we must remember that any results gathered from that and other trials only apply to few patients.What about the patients who did not qualify for the trial? How should that data be applied to them? Does that treatment work for them at all?
       A recent review of the literature concluded that the quality of information generated by randomized controlled trials is generally poor.⁶ The FDA has approved only 3 advanced therapeutic products based on efficacy of healing—Regranex gel (1997), Aligraf (1998 for VLU, 2000 for DFU),and Dermagraft (2001 DFU). Of those 3 products said to be proven effective by randomized controlled trial for treatment of the approved disease,the best healing rates are 62% at 24 weeks for venous leg ulcers,⁷ and 58% at 12 weeks for diabetic foot ulcers.⁸ If we treat patients with the best available therapy and still only heal slightly more than half, what are we to do for patients who do not heal with the “evidence-based, best therapy”?
       As wound care providers, people in charge of reimbursement, regulatory authorities, all of us, look to determine what is the best therapy for our patients, we must never lose sight of the fact that evidenced-based practices are guidelines, nothing more. They should never replace clinical experience and judgment or replace care tailored to the individual patient.^9–11 We are still in the business of treating patients and not diseases. It is our obligation to do what is best for each individual patient, nothing more, nothing less.