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The economic impact of infection on venous leg ulcers

13th December 2022

Addressing an old wound

Venous leg ulcers (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, and prevent backflow of blood to the heart – a condition known as 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, which can ultimately lead to ulceration.

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Chronic wounds, including VLUs, represent a silent epidemic for healthcare systems around the world; between one and three percent of adults above 60 suffer with chronic leg ulcers, increasing to more than five percent in adults above 80.1  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 – a figure representing approximately 200,000 people.

A heavy burden

As with most chronic wounds, the risk of developing a VLU increases with age – 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 an aging and an increasingly overweight population5, negatively impacting patients and putting additional strain on already burdened healthcare services.

VLUs have a significant – and at times debilitating – 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 loss.6 This physical and emotional burden lasts until the wound heals, although VLUs are typically slow to heal and difficult to treat. 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 healing (estimated at 57 percent8).

The true impact of infection

As a direct result, 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 weeks.9 In these cases, the wound may itch, puss and release an unpleasant smell, which can cause distress, discomfort, and embarrassment. If left untreated, infected wounds can lead to septicaemia (blood poisoning) and even limb amputation.

Combating VLU infection places a “unique economic burden on healthcare systems” according to a case-control study from Melikian et al.10 The study of VLU patients in the United States found active infection of the wound was the most frequent cause for inpatient treatment, responsible for 61 percent of inpatient admissions with the need for intravenous antibiotics.

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.

Setting new standards

An effective way to combat the risk of infection is to close the wound bed area as quickly as possible, limiting its exposure to harmful bacteria. The current standard of care (SOC) consists of dressings, compression therapy and exercise to promote blood flow in the deep veins of the calf to achieve this.

Compression therapy involves using medically prescribed compression bandaging or stockings to reduce vein distension, 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.

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

Tech takes the lead

Tackling VLU infection requires a two-pronged approach: whilst intravenous antibiotics do not heal VLUs they are used to fight an existing infection, and alongside these is medical technology (MedTech) often used in combination with existing SoC to enhance leg ulcer healing in non-infected patients – and to help reduce wound infection risk in the first place.

A good example is an innovation supported with two recent studies (Das12,13 and Bosanquet14). Both explored the effect of a neuromuscular electrostimulator (NMES) – the geko™ device – on wound healing. This innovative MedTech therapy (used in combination with compression therapy) stimulates the common peroneal nerve activating the calf and foot muscle pumps, resulting in increased venous, arterial, and microcirculatory blood flow – delivering oxygen rich blood to the wound edge and bed. Both studies measured flux and pulsatility, key elements associated with wound healing and report significant increases in both – 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.

Tackling the financial burden

Technological advancements of this nature mark a new era in the treatment of VLUs, to address the physical and emotional impact on patients but also to release cost savings for the healthcare systems – helping more people receive the care they need sooner.

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