Wound Care Providers Should Have Some Skin in the Game

Dear Readers:

My good friend Windy Cole, DPM, an Editorial Board Member of Wounds, has written an impassioned letter to remind all of us to participate in good quality clinical research. She reminds us of the resources and dedication it takes to design, collect, complete, and analyze clinical research. There are so many questions that need to be answered, and work that needs to be done in so many wound etiologies. As a profession, we need to engage with the atypicals—pyoderma gangrenosum, hidradenitis suppurativa, rheumatoid arthritis, and so many more. Seek out mentors, such as Dr. Cole, if you want to make research meaningful. 

Thank you, Dr. Cole, for your dedication to advancing the field. 

John C. Lantis II, MD, FACS
Editor-in-Chief, Wounds
woundseditor@hmpglobal.com

 

Dear Readers:

In the field of wound care, skin substitutes—also referred to as cellular and tissue-based products (CTPs) or by the updated nomenclature of cellular, acellular, and matrix-like products (CAMPs)—have been shown to improve healing rates in some wound types and are cost-effective when used properly. Earlier this year, all 7 Medicare Administrative Contractors (MACs) proposed a change to their individual Local Coverage Determinations (LCDs) focusing on CAMPs. After an evidentiary review of published literature available, the MACS proposed changes to the LCD restricting coverage of CAMPs to 15 products and, more importantly, limiting application to total of 4 per wound duration. Note that per the LCD language the clinician can ask for more applications, if they are effective. This is obviously an attempt to decrease expenditures. Many of the products that the LCDs do cover actually require a median of 6 applications to close a wound. In part what these MACs appear to be doing is attempting to limit the CAMP usage on wounds that do not improve. If adopted, these updated LCDs will substantially change the way wound care is delivered across the continuum of care. 

Besides lobbying efforts, the best way to provide the care we need for our patients is through the generation of high-quality evidence. The data generated from wound care clinical trials has been used to generate consensus documents and international guidelines, outlining the best practices for chronic wound management.^1-3 When these guidelines are adhered to, care delivery is optimized to provide better patient outcomes, improved utilization of resources, and more cost-effective care. This has to include smarter ways to limit the use of products in wounds that are not improving.

Evidence-based decision-making has become the foundation of 21st-century medicine and should be embraced in the field of wound management. Thus, there is a great need to continue to generate well-established level one evidence from prospective, multicenter randomized controlled trials demonstrating superior patient outcomes for various treatments and devices, including but not limited to CAMPs. These trials need to include algorithms of care which may not support only one company’s product line. 

Wound care specialists of all backgrounds have a key role to play in research. By participating in clinical trials, wound care specialists can contribute to the science of medicine and encourage the adoption of best practices in care delivery. But keep in mind, research is a team sport. Vital members of the team are the clinical investigator and the clinical research assistant. These dedicated individuals should be inquisitive, possess good project management skills, be able to extract and manage data, and adhere to the trial protocol. Clinicians that are unable to directly participate in a clinical trial as a researcher can still be valuable as a referral source of patients. I encourage you to visit https://clinicaltrials.gov/ to become familiar with current trials in your area.

As a call to action to wound care specialists, I would like to personally invite you to become more involved in current ongoing research initiatives. Evidence-based practices help clinicians to critically evaluate new evidence and develop the best practice algorithms important for supporting the patient journey, illustrating medical necessity, and justifying claims payments. Additionally, clinical trial participation benefits patients by providing access to innovative therapies and compensation for time and travel. 

Together, we can help to drive the development of advanced, cutting-edge therapies to help our at-risk patients. If you are interested in additional information on how you can get involved in wound care research, please feel free to contact me at wcole4@kent.edu.  

Windy Cole, DPM, CWSP, FFPM RCPS (Glasg)

References

1. ElSayed NA, Aleppo G, Aroda VR, et al. 12. Retinopathy, neuropathy, and foot care: standards of care in diabetes—2023. Diabetes Care. 2023;46(Suppl 1):S203-S215. doi:10.2337/dc23-S012

2. Schaper NC, van Netten JJ, Apelqvist J, et al; IWGDF Editorial Board. 2023 IWGDF Guidelines on the prevention and management of diabetes-related foot disease. 2023. Accessed September 17, 2024. www.iwgdfguidelines.org

3. Lavery LA, Suludere MA, Attinger CE, et al. WHS (Wound Healing Society) guidelines update: diabetic foot ulcer treatment guidelines. Wound Repair Regen. 2024;32(1):34-46. doi:10.1111/wrr.13133