The Plight of the Standard of Care

Dear Readers:

What is the standard of care for the chronic wound? As we know it, “standard of care” is an unfortunate legal term, which means “the degree of skill and care of the average doctor practicing in the same field during the relevant time period.”¹ We as a practicing body have allowed the term to slip into our lexicon, especially in prospective randomized trials. Obviously, we want to be evaluating new therapies against our best clinical or best current practices.

For more than 20 years, we have excused ourselves from this debate by claiming that the FDA has told us that there is no “standard of care” other than wet-to-dry dressings; although in meetings with the FDA, I have not heard them say that. In addition, most trials are performed in the post-market environment. Unfortunately, the sponsors of these trials often choose a suboptimal standard of care. In part, this helps to ensure that the active therapeutic has a better chance of statistically outperforming its comparator. Our research group, like many, has participated in these ubiquitous trials investigating various outcomes in Wagner grade 2 diabetic foot ulcers. As long as total contact casting is not allowed in the trial, we can almost count on the standard of care to close approximately 35% of wounds at 12 to 16 weeks.  

However, for no investigator is, a hydrogel, petrolatum, collagen, or hydrofiber their best clinical or current practice for a Wagner grade 2 diabetic foot ulcer. Therefore, the clinician—whose first responsibility is to their patient—will have a very hard time randomizing the patient to these less-effective therapies. All providers have options for patients with diabetic foot ulcers that we know close more than 60% to 70% of patients after 12 weeks of therapy. Those are the therapies we need to be comparing against the next generation of therapeutics.

In other less-studied areas, it is more challenging to define best clinical/current practices. A Wagner grade 3-4 diabetic foot ulcer may bear more discussion, as does a venous leg ulcer, atypical ulcer, pressure injury, or traumatic injury. However, in none of these wound types is a wet-to-dry dressing the answer. I and other colleagues are of the mindset to move away from writing about or using the term of “standard of care” in the clinical literature. A question the Wounds Editorial Board and referees will be asking of authors is: How and why did you decide on your control arm therapy? 

The argument can be made that we should not only move to use the terminology of best clinical/current practice, but also design studies that implement those practices. If a study sponsor states there is no best clinical/current practice in an area, they are misguided. In 2023, that sponsor must discuss with its key opinion leaders and/or its local principal investigators what their best clinical/current practice is for that wound entity. This discussion must occur before completing the design and power calculations of the study. An example of this process can be seen with a current sponsor of a pressure injury trial that has agreed that negative pressure wound therapy will be the control arm. With harnessed clinical expertise, we can inform the FDA of what is the best clinical/current practice for a wound type and that there is enough data to support its use or, if not, validate the selected therapy. If sponsors do not move in this direction, enrollment in trials will suffer. In most wound types (except atypical wounds), there are current clinical therapies that achieve 65% to 70% wound closure. Arguably, enrolling patients into a trial in which the control arm is known to be worse than our best current/clinical practice is unethical and will become more so with each passing year. 

John C. Lantis II, MD, FACS

Editor-in-Chief, Wounds

Wounds. 2023;35(7):A8 woundseditor@hmpglobal.com

Reference

1. Vanderpool D. The standard of care. Innov Clin Neurosci. 2021;18(7-9):50-51.