Clinical Trials

Thomas Serena's picture
Wound Care Clinical Trials

By Thomas E. Serena MD, FACS, FACHM, FAPWCA

A recent article by Kaiser Health News misquoted me as saying that we enroll only "healthy" patients in our clinical trials. At moments like this, one feels that something has been overlooked. One of my research coordinators, recalling the serious adverse events (SAEs) of the previous week said, "The only patients sicker than ours are underground."

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Thomas Serena's picture
clinical research in wound care

by Thomas E. Serena, MD, FACS, FACHM, FAPWCA

The ancients sacrificed a brown dog at the beginning of the Dog Days to appease the rage of Sirius, believing that the star was the cause of the hot, sultry weather. Why a brown dog? I wonder. I think it more appropriate to register a complaint with the concierge that the air conditioner in my room is acting strange and performing poorly. But the dog days of Summer 2016 are upon us with a menacing bark and a harsh bite. I am lethargic. I am uncomfortable. I wondered whether to blog or not.

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Thomas Serena's picture
standardizing clinical trial endpoint

by Thomas E. Serena MD, FACS, FACHM, FAPWCA

Recently, I had the pleasure of attending Puccini's opera Turandot at New York's Metropolitan Opera House. In my favorite scene, young prince Calef comes upon a gruesome tableau: Potential suiters for the princess Turnadot must answer three questions correctly in order to win her hand. On the downside, one incorrect answer is rewarded with a beheading. Calef takes the challenge and answers all three questions flawlessly. Yet, the princess begs her father not to force her to marry the stranger. Calef intercedes saying that if she can guess his name before dawn he will release her from her obligation. Confident of conquest, he sings Nessun dorma (none shall sleep), the opera's most famous aria.

Michel Hermans's picture
Year in review

by Michel H.E. Hermans, MD

At the beginning of a new year, many look back at the previous one in an attempt to analyze what happened, whether it was good or bad or perhaps even special.

From a chronic or acute wound healing point of view, 2015 was not particularly special. Yes, a number of new dressings and techniques were launched at the different conferences, but none of them really established a breakthrough with regard to new clinical data or a totally new approach to many of the still unsolved problems that exist in healing wounds.

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Temple University School of Podiatric Medicine's picture
Wound Care Literature Review

Temple University School of Podiatric Medicine Journal Review Club

Editor's note: This post is part of the Temple University School of Podiatric Medicine (TUSPM) journal review club blog series. In each blog post, a TUSPM student will review a journal article relevant to wound management and related topics and provide their evaluation of the clinical research therein.

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Journal Club Review

Temple University School of Podiatric Medicine Journal Review Club

Article title: Treatment with LL-37 is safe and effective in enhancing healing of hard-to-heal venous leg ulcers: a randomized placebo controlled clinical trial.
Authors: Alvar Gronberg, DrMedSc; Margit Mahlapuu, PhD; Mona Stahle, MD, PhD; Caroine Whately-Smith, CStat; Ola Rollman, MD, PhD.
Journal name and issue: Wound Repair and Regeneration, September-October 2014 (pages 613-621).
Reviewed by: Lucy Barrow, Temple University School of Podiatric Medicine

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Thomas Serena's picture
Hyperbaric Chamber

by Thomas E. Serena MD, FACS, FACHM, FAPWCA

Pete Seeger died a year ago last January at the age of 94. Reading a tribute to the folk singer, I ran across his most memorable tune, "Where have all the flowers gone?" I have long enjoyed the numerous versions of this folk song recorded by dozens of artists. The fatalism of the lyrics and the circular verse form made it emblematic of a most unfortunate decade in American life: the 60s.

Michel Hermans's picture

by Michel H.E. Hermans, MD

Merriam Webster defines bias as "selecting or encouraging one outcome or answer over others." The Cochrane handbook states: "The reliability of the results of a randomized trial depends on the extent to which potential sources of bias have been avoided."

When designing a trial or even animal research, avoiding bias is difficult. In fact, it may be introduced unknowingly or deliberately.

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Michel Hermans's picture

Part 2 in a series on clinical trials in wound care
For part 1,
click here.
by Michel H.E. Hermans, MD

In the first part of this series on the challenges of conducting clinical trials in wound care, I discussed factors that include patient populations and lesion prevalence. Additional criteria and conditions of the clinical trial will be further examined in this blog.

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Michel Hermans's picture

Part 1 in a series on clinical trials in wound care

by Michel H.E. Hermans, MD

To do a Randomized Controlled Trial within a reasonable time frame, the disease to be studied should be common and the patient population large and accessible. In addition, preferably the effect of the treatment should be fast and specific.

In the pharmaceutical environment these circumstances often exist. Nearly 68 million people in the US suffer from hypertension1,2 and it should be easy to find patients for a clinical trial. The study objective is also relatively simple: lowering blood pressure (of course I am simplifying here).