Podiatrists Should Have Skin in the Game—Getting Involved in Research is a Start
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In the field of wound care, CAMPs (cellular, acellular, and matrix-like products)—also referred to as cellular and tissue-based products (CTPs)—have shown improved healing rates and cost-effective care when used as a part of evidence-based clinical algorithms.1,2 Recently the 7 Medicare Administrative Contractors (MACs) proposed an update to Local Coverage Determinations (LCDs) governing the application of CAMPs in diabetic foot ulcer and venous leg ulcer management.3,4 The proposed changes will restrict coverage of CAMPs to roughly 15 products and limit applications to a total of 4 per wound duration. If adopted, this updated LCD will substantially change the way wound care is delivered across the continuum of care.
Evidence-based decision-making has become the foundation of 21st-century medicine and is a welcome approach within wound care. Thus, generating well-established Level 1 evidence from prospective multicenter randomized controlled trials demonstrating superior patient outcomes is becoming increasingly important.
Podiatrists have a key role to play in research as we are diabetic foot experts. By participating in research, podiatrists can contribute to the science of medicine and encourage the adoption of best practices in care delivery. Every one of us has a role in supporting research—either by participating in clinical trials or referring patients for enrollment in current studies. Evidence-based practices help podiatrists critically evaluate new evidence and develop the best practice algorithms important for illustrating medical necessity and supporting claims payments.
I would like to personally invite all podiatrists to become more involved in ongoing research initiatives. Opportunities are available to get involved as a trial site or by referring your patients for participation in current trials. Benefits to patients enrolled in clinical trials typically include access to innovative therapies and compensation for time and travel.
Participation in clinical research allows HCPs to reignite their interest in the advancement of medicine and make more informed treatment decisions.5–7 Information gained from research is used to generate evidence-based treatment algorithms to support better care. Additionally, running a clinical trial site at your practice can allow you to offer novel therapies to your patients which can result in meaningful outcome. Moreover, participation in clinical trials allows clinicians to collaborate with other healthcare professionals, co-author articles, and network. By doing so providers can enhance their reputation in the community and with healthcare leaders adding prestige to their practice or institution.
Together, we can help to develop advanced, cutting-edge therapies to help our at-risk patients. For more information on getting involved in research or current trials recruiting patients please contact Windy Cole, DPM at wcole4@kent.edu.
Dr. Cole is the Director of Wound Care Research for Kent State University College of Podiatric Medicine.
References
1. Vecin NM, Kirsner RS. Skin substitutes as treatment for chronic wounds: current and future directions. Front Med (Lausanne). 2023 Aug 29;10:1154567. doi: 10.3389/fmed.2023.1154567. PMID: 37711741; PMCID: PMC10498286.
2. Nherera LM, Banerjee J. Cost effectiveness analysis for commonly used human cell and tissue products in the management of diabetic foot ulcers. Health Sci Rep. 2024 Mar 22;7(3):e1991. doi: 10.1002/hsr2.1991. PMID: 38524772; PMCID: PMC10958527.
3. Centers for Medicare and Medicaid Services. CMS Statement on Proposed Local Coverage Determination (LCD) for Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers. Published April 24, 2024. Accessed Oct. 1, 2024.
4, Centers for Medicare and Medicaid Services. MCD search results. Accessed Oct. 1, 2024.
5. Physician Side Gigs. Clinical Research Opportunities for Physicians. Accessed Oct. 21, 2024.
6. Bhuiya T, Makaryus AN. The importance of engaging in scientific research during medical training. Int J Angiol. 2023 Jan 17;32(3):153-157. doi: 10.1055/s-0042-1759542. PMID: 37576537; PMCID: PMC10421692.
7. Lazas D. How Integrating Clinical Trials Into Private Practice Can Benefit Both Patients, Physicians. Pharmacy Times. Published May 9, 2023. Accessed Oct. 21, 2024.
