Venous Leg Ulcers; Economics and MedTech’s Answers

geko venous leg ulcer prevention

Technological advancements such as Sky Medical Technology‘s wearable geko™ device mark a new era in the treatment of Venous Leg Ulcers (VLU), says the company’s CEO and founder Bernard Ross. As much as they address the physical and emotional impact on patients, new therapies can also represent cost savings for embattled healthcare systems.

Sky Medical Technology CEO Bernard Ross
Sky Medical Technology’s CEO and founder Bernard Ross

Background

VLUs are chronic skin ulcers that develop in the gaiter area (below the knee and above the ankle). They are a result of damaged or blocked veins in the leg caused by trauma, deep vein thrombosis, varicose veins, or oedema. VLUs typically prevent backflow of blood to the heart, so-called chronic venous insufficiency (CVI). CVI triggers a build-up of blood in the lower leg that can lead to substantial ankle oedema and changes in the skin’s structure. This can ultimately lead to ulceration and all its deleterious effects.  

Between one and three percent of adults above 60 suffer with chronic leg ulcers, increasing to more than five percent in adults above 801. Venous leg ulcers (VLUs) are the most prevalent type of leg ulcer, making up approximately 80 percent of all cases2 and affecting between 0.1 – 0.3 percent of the UK population3, approximately 200,000 people. 

Venous Leg Ulcers; Impact for Patients

As with most chronic wounds, the risk of developing a VLU increases with age. Indeed prevalence doubles among those older than 65 years4. The number of people with VLUs across the globe is expected to continue to rise in the future due to increasing age profile. Exarcebated by an increasingly overweight population5, the result adds strain to already burdened healthcare services.

VLUs have a significant negative impact on the quality of life of patients, causing extreme pain and an impeded ability to walk or sleep. This can lead to deteriorated mental health and sometimes further physical consequences, including involuntary weight loss6. This physical and emotional burden lasts until the wound heals, although VLUs are typically slow to heal and difficult to treat. In fact only 53 percent heal within one year7 and some never heal at all, with more than half of patients experiencing recurrences within a year of healing8

The Numbers

Many VLU sufferers also find themselves battling infection. A study conducted by Bui et al found that in a group 636 patients with mixed leg ulcers (75 percent venous) 15.9 percent developed clinical infection within 12 weeks9. This can mean itching, pus and bad odours, all of which can range from the uncomfortable to the embarrassing. If left untreated, infected wounds can lead to septicaemia and even limb amputation.

Combating VLU infection places a “unique economic burden on healthcare systems”10

Nine of 78 patients with a VLU (11.5 percent) followed for at least one year had a minimum of one inpatient admission for infection. Within that infected cohort, 44 percent had an unhealed ulcer at the end of the one-year follow up period, compared to just 13 percent in the non-infected group. 

When compared with the 69 patients without infection, the total cost of treating infected patients ($27,408) was nearly three times greater than non-infected ($11,088). Visiting Nurse Association costs were also twice as high for infected VLUs versus those with no infection.

The high prevalence of VLUs in the United States sees the healthcare system treating 500,000 – 600,000 cases every year, with VLU patients consuming more medical resources at a much higher cost than non-VLU patients. Cost per patient per year indicates: $18,986 VLU vs $12,595 non-VLU for Medicare and $13,653 VLU vs $6,623 non-VLU for private payers.11

The Melikian et al study clearly emphasises the importance of preventing infection in patients with VLUs due to its major impact on both medical resources and costs, as well as on ulcer healing and patient health.

Typical Treatment for Venous Leg Ulcers

There is no recognised international gold standard of care for VLUs, despite it being a widespread and prevalent global healthcare issue. This means that management can differ patient to patient, and location to location. The result is often low adherence, an increased risk of infection and, ultimately, a higher financial burden for healthcare systems to manage.

Typical treatment consists of dressings, compression therapy and exercise to promote blood flow in the deep veins of the calf. Compression therapy involves using medically prescribed compression bandaging or stockings to reduce vein distention, activating the calf muscle pump to push blood back to the heart and reduce oedema. Compression therapy comes in various forms, including four-layer, two-layer, hosiery kits and wraps, dependent on the level of compression required for optimal healing as well as the patient’s pain tolerances. It is important to note that compression therapy is contraindicated for some patients who therefore need an alternative treatment method. 

Adoption of Tech Solutions

Medical technology is finding a place in VLU prevention and treatment. Clinicians increasingly apply new therapies alongside existing standard of care to enhance leg ulcer healing in non-infected patients. Indeed technology can help reduce wound infection risk in the first place.  

A good example is Sky Medical Technology’s geko™ neuromuscular electrostimulator (NMES) device, which can also augment traditional compression therapy. The wearable geko™ unit stimulates the common peroneal nerve, activating the calf and foot muscle pumps. It delivers painless electrical impulses to stimulate blood flow, without the patient having to move. This results in increased venous, arterial, and microcirculatory blood flow. This in turn delivers oxygen rich blood to the wound edge and bed.

Two recent studies12,13,14 explored the effect of the geko™ device on wound healing. The studies reported significant increases in both flux and pulsatility, key elements associated with wound healing. The latter is of particular pertinence, since pulsatile flow is a predicter of wound healing.

The augmentative effect of NMES on the microcirculation, both in terms of flux and pulsatility, provides a mechanistic insight into the geko™ device and its efficacy in wound healing. Moreover, geko™ is being adopted into healthcare systems globally to treat a range of medical conditions including the prevention of venous thromboembolism and the treatment and prevention of oedema.

Source: Adapted from an article by Bernard Ross, CEO and Founder of Sky Medical Technology Ltd.

References

1 Shubhangi Vinayak Agale, “Chronic Leg Ulcers: Epidemiology, Aetiopathogenesis, and Management”, Ulcers, vol. 2013, Article ID 413604, 9 pages, 2013. https://doi.org/10.1155/2013/413604

2 National Health Service. (2019) Overview: venous leg ulcers. Available at: https://www.nhs.uk/conditions/leg-ulcer/

3 National Institute of Health and Care Excellence (NICE). Leg ulcer – venous. 2021. https://cks.nice.org.uk/topics/leg-ulcer-venous/

4 Pérez MB, López‐Casanova P, Lavín RS. Recent Reports from University of Alicante Highlight Findings in Leg Ulcers [Epidemiology of venous leg ulcers in primary health care: Incidence and prevalence in a health centre-A time series study (2010-2014)] Citation metadata. Int Wound J 2018; 16: 256–65.

5 Probst et al, 2021: https://systematicreviewsjournal.biomedcentral.com/articles/10.1186/s13643-021-01697-3

6 DeSanti L. (2000). Involuntary weight loss and the nonhealing wound. Advances in skin & wound care, 13(1 Suppl), 11–20. Available at: https://pubmed.ncbi.nlm.nih.gov/11061713/

7 Guest JF, Fuller GW, Vowden P. Venous leg ulcer management in clinical practice in the UK: costs and outcomes. Int Wound J 2018;15:29–37 https://doi.org/doi:10.1111/iwj.12814pmid:http://www.ncbi.nlm.nih.gov/pubmed/29243398

8 Finlayson K, Wu M-L, Edwards HE. Identifying risk factors and protective factors for venous leg ulcer recurrence using a theoretical approach: a longitudinal study. Int J Nurs Stud 2015;52:1042–51 https://doi.org/doi:10.1016/j.ijnurstu.2015.02.016pmid:http://www.ncbi.nlm.nih.gov/pubmed/25801312

9 Bui UT, Finlayson K, Edwards H. Risk factors for infection in patients with chronic leg ulcers: a survival analysis. Int J Clin Pract 2018;72: e13263: https://onlinelibrary.wiley.com/doi/10.1111/ijcp.13263 

10 Melikian et al: The economic impact of infection requiring hospitalization on venous leg ulcers, Journal of Vascular Surgery: Venous and Lymphatic Disorders [January 2022]. 

11 Rice JB, Desai U, Cummings AK, Birnbaum HG, Skornicki M, Parsons N. Burden of venous leg ulcers in the United States. J Med Econ 2014;17:347-56.

12 Das, SK, Dhoonmoon, L, Chhabra, S. Neuromuscular stimulation of the common peroneal nerve increases arterial and venous velocity in patients with venous leg ulcers. Int Wound J. 2021; 18: 187– 193. https://doi.org/10.1111/iwj.13510

13 Das SK, Dhoonmoon L, Bain D, Chhabra S. Microcirculatory changes in venous leg ulcers using intermittent electrostimulation of common peroneal nerve. J Wound Care. 2021 Feb 2;30(2):151-155. https://doi.org/10.12968/jowc.2021.30.2.151.  PMID: 33573484.

14 Bosanquet D, Ivins N, Jones N, Harding K. (2020). Microcirculatory Flux and Pulsatility in Arterial Leg Ulcers is Increased by Intermittent Neuromuscular Electrostimulation of the Common Peroneal Nerve. Annals of Vascular Surgery. https://doi.org/10.1016/j.avsg.2020.07.030

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