The Pressing Need For New Strategies to Treat Diabetic Foot Ulcers 

A recent trial showed a significant reduction in wound area by 73.1% with Single Use Negative Pressure Wound Therapy System (sNPWT). 

The critical link between long-term chronic wounds, poor quality of life, and increased risk of mortality, is an issue drawing urgent attention amongst health professionals. 

According to the American Diabetes Association, in 2018 34.2 million Americans, or 10.5% of the population, had diabetes,¹ and the prevalence of diabetic foot ulcers (DFUs) among patients with diabetes is estimated to be 13% in North America.² 

These are serious statistics given that 85% of lower limb amputations are preceded by the development of a neuropathic foot ulcer.³ For diabetes patients with ulcers, the risk of death is increased 2.5-times compared with diabetes patients without foot wounds.⁴ 

For an issue this dangerous, new strategies are needed. Understanding the etiology of the ulcer and its link with a patient’s lifestyle is insightful and assists in defining the general management approach; however, the potential role of new technological interventions must not be underestimated. Indeed, there is much innovation taking place, the adoption of which in routine clinical practice could have far-reaching effects. 

A growing body of evidence 

A growing body of evidence is emerging to recommend the use of negative pressure wound therapy (NPWT) in the management of patients with delayed healing or stalled lower extremity wounds. While earlier versions of this canister-based technology have been highly effective clinically vs. standard care, they retain limitations in their practical mobility, use in a post-acute or home setting, and overall clinical management. 

The technology, however, has been evolving from canister-based platforms of treatment to smaller, highly portable, single–use versions; and research is showing a remarkable improvement over an already proven and practical methodology. 

A recent multicenter randomized controlled trial (RCT)⁵ carried out by Robert Kirsner et al., across 16 U.S. and 2 Canadian hospitals, looked at wound closure when comparing the use of PICO™ Single Use Negative Pressure Wound Therapy System (sNPWT) with traditional NPWT (tNPWT) in the management of patients with lower extremity ulcers (DFUs and VLUs) over 12 weeks. 

The results were promising, showing a significant reduction in wound area (by 73.1%), depth (by 48.1%), and a reduction (of 61%) in overall wound volume when sNPWT was used. 

As well as improved clinical outcomes, the study also noted a reduction in the number of dressing changes as sNPWT could be worn, on average, 3.4 days longer (6.5 vs. 3.1 days). Not only does this have clear benefits in terms of reducing nursing time, but patients are also required to attend fewer dressing change appointments, which can become a barrier to living a healthy life. 

Furthermore, in an economic analysis of the data switching from tNPWT to sNPWT would result in an estimated cost savings of $7,756 per patient over 12 weeks and an estimated cost reduction of $15,749 over 26 weeks.⁶ 

The economic burden 

Time to closure, frequency of dressing changes, and incidence of complications are well- established factors driving the cost of wound care. DFUs impose a substantial cost burden on the U.S. health system, estimated between $9 to $13 billion, in addition to the cost for management of diabetes alone.² 

Existing methodologies of intervention need updating. The appropriate use of innovative and clinically proven wound management technologies can and must play their part in a step-change strategy. 

This may require an evolution in the goal–setting, clinical practice, and procurement process. Still, the upside of a coordinated effort is a direct impact on a significant area of medicine that will improve the quality of life and reduce mortality. 

Innovation should be at the forefront 

The recent evidence from Dr.Kirsner‘s study highlights how the adoption of technology and new treatment pathways can help to alleviate some of the current pressures. With an aging population and the projected rise in diabetes, it is vital more than ever that a strategy is in place to address the burden of wound care and ways to improve patients‘ quality of life. This includes embracing innovations that disrupt the inefficiencies that we are currently facing with wound care practice. 

Practice Pearls: 

• A growing body of evidence is emerging to recommend the use of negative pressure wound therapy (NPWT) in the management of patients with delayed healing or stalled lower extremity wounds.  
• The study also noted a reduction in the number of dressing changes, which has clear benefits such as reduced nursing time and fewer dressing change appointments, which can become barriers to living a healthy life. 
• A recent multicenter randomized controlled trial showed a significant reduction in wound area (by 73.1%), depth (by 48.1%), and a reduction (of 61%) in overall wound volume when single–use NPWT was used. 
• Switching from traditional to single–use NPWT could result in an estimated cost savings of $7,756 per patient over 12 weeks and an estimated cost reduction of $15,749 over 26 weeks. 

For more information on the Kirsner study: 

https://onlinelibrary.wiley.com/doi/full/10.1111/wrr.12727 

1. Economic Costs of Diabetes in the U.S. in 2017. American Diabetes Association. Diabetes Care 2018 Mar; dci180007.https://doi.org/10.2337/dci18-0007 
2. Raghav A, Khan ZA, Labala RK, Ahmad J, Noor S, Mishra BK. Financial burden of diabetic foot ulcers to world: a progressive topic to discuss always. Ther Adv Endocrinol Metab. 2018;9(1):29–31. doi:10.1177/2042018817744513 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5761954/
3.  https://physiotherapy.ca/impact-chronic-lower-leg-ulcers-within-senior-population-and-role-exercise-fall- 2014 
4. Brownrigg JRW, Griffin M, Hughes CO, Jones KG, Patel N, Thompson MM, Hinchliffe RJ. Influence of foot ulceration on cause-specific mortality in patients with diabetes mellitus. J Vasc Surg. 2014;60(4):982–986. doi: 10.1016/j.jvs.2014.04.052. 
5. Kirsner R, Dove C, Reyzelman A, Vayser D, Jaimes H. A Prospective, Randomized, Controlled Clinical Trial on the Efficacy of a Single‐use Negative Pressure Wound Therapy System, Compared to Traditional Negative Pressure Wound Therapy in the Treatment of Chronic Ulcers of the Lower Extremities. Wound Rep Regen. https://doi.org/10.1111/wrr.12727.
6. Robert S. Kirsner, MD, Ph.D.; Gary Delhougne, J.D., MHA; and Richard J. Searle, PhDA Cost-Effectiveness Analysis Comparing Single-use and Traditional Negative Pressure Wound Therapy to Treat Chronic Venous and Diabetic Foot Ulcers Wound management & Prevention.  March 2020 | vol. 66, no. 3 

Dr. Cyaandi R. Dove, D.P.M graduated from the University of Florida in Gainesville, Florida. After college, Dr. Dove continued her studies at California College of Podiatric Medicine in San Francisco, CA, where she earned the Degree of Doctor of Podiatric Medicine. She also completed her Post Graduate Training at The University of Texas, Health Science Center in San Antonio, Texas. She completed a surgical fellowship at North General Hospital, in New York, NY. Before practicing in Las Vegas, Dr. Dove was the director of podiatry at the Diabetic foot and Ankle Center – Hospital for Joint Disease – NYU. Dr. Dove is also involved in research and has multiple publications in peer-reviewed journals. She participates in numerous industry sponsored clinical trials, which offer the latest technology available.