Peripheral Vascular Disease

Can a home use medical device be used to treat Peripheral Vascular Disease?

Based on an article titled “Patient and clinician experiences and opinions of the use of a novel home use medical device in the treatment of peripheral vascular disease - a qualitative study”

Originally written by: Sedgwick et al., 2021 

https://jfootankleres.biomedcentral.com/articles/10.1186/s13047-021-00496-2

By: Murielle Nsiela 

Peripheral artery disease (PAD), also known as peripheral vascular disease, is a common circulatory condition whereby fatty deposits in the arteries cause the narrowing of arteries, which restricts blood flow to the limbs. This process is called atherosclerosis. The disease can affect both arms and legs but mostly impacts the legs. 1,2 In the UK, 20% of the population aged 55 to 75 years have been found to have evidence of PAD.3 However, the disease has already affected 202 million individuals worldwide as of 2010.4 The disease severely impacts patients’ quality of life, affecting everyday life activities and life expectancy. 

Many individuals with PAD usually have no symptoms and may not be aware of the disease's presence. However, some individuals develop pain in their legs, mostly from walking, which can be severe or mild. The symptoms develop slowly and over a period of time. This pain diminishes after resting and may occur on both legs; however, one leg can be affected more than the other. Moreover, the medical term for this leg pain is known as intermittent claudication.2 Other symptoms of the condition include numbness or weakness of the legs, ulcers (open sores on feet or legs) that do not heal, change of skin colour on legs, muscles of the leg shrinking, hair loss on feet or legs, and erectile dysfunction in men.2 Despite the prevalence of the disease, it remains underdiagnosed and undertreated. In addition, the course of treatment imposes a significant economic burden, especially in developing countries. 

Therefore, adequate treatment methods are crucial as leg amputation is possible if this condition is left untreated. Some studies have found ways to reduce deterioration by increasing awareness of the condition and lifestyle modifications.5 Lifestyle changes include exercising regularly to improve quality of life, stopping smoking to prevent the disease from becoming more aggressive, eating a healthy and balanced diet, and reducing alcohol consumption.2 However, these changes are hindered by poor uptake and accessibility for some.6 Therefore, other effective treatment measures are required to improve blood circulation and promote limb wound healing.7 

Recently, there have been improvements for chronic wounds using negative pressure wound therapy for patients with PAD. It has successfully been applied in primary home care settings.8 The recent development of a medical device called FlowOx™ Otivio that applies intermittent negative pressure on the lower leg and not on the wound has shown to provide massive improvements. This includes enhancement in micro and macro-circulation, in addition to improving healing in wounds that have proven to be challenging to heal. The positive effects of intermittent negative pressure have been due to several factors. For example, it may be due to the increase in arterial pressure gradient 9, blood flow fluctuations and shear rate10, which have all improved endothelial function.11,7 Plus, published data has revealed that intermittent negative pressure treatment showed improvement in pain-free walking for long distances after 12 weeks of treatment.12 

A follow-up study was conducted with a treatment time of 24 weeks. The results showed that individuals could walk pain-free, and their maximum walking distance had increased.13 The medical device FlowOx™ is CE 14 marked and is intended for use for patients with PAD; the device is recommended by clinicians to be used for two hours. As the device is for home use, it is essential to establish safety, suitability and acceptability for patient use. Therefore, patient and clinician interviews were conducted to determine the patients’ opinions on the self-use medical device’s usability, value, and design. The clinicians were also interviewed to determine the clinical effects and benefits and financial benefits of Norway’s healthcare.7 

The results 

Patient interviews

Most patients from the interviews stated that the device was easy to use, and they were able to independently handle it. However, there were some issues as it was postulated that the elderly may have some difficulties in using the device. In terms of patients' experiences, some individuals stated that they were 100% happy with using the device, and some had also noted that the device had helped improve the health of their limbs. However, some individuals complained about not being able to walk after treatment. Additionally, regarding the value, most patients stated that it was worth the price as it improves everyday limb function, with some calling the device a “wonder machine”.7 

Clinician interviews

Most clinicians thought that the device could potentially save limbs. Furthermore, others also thought that if the device provided healing to wounds and did not meet other parameters, then they would still recommend using the device. Some clinicians reported concerns about the patient groups that would benefit most from the device and about determining when in the disease process it would be suitable to introduce the use of the device. Although there is no specific category, some clinicians stated that the device could be helpful as a last resort. Furthermore, clinicians also agreed that the device is easy to use with simple instructions and low adverse effects.7 

Summary

In summary, PAD is a condition that can heavily impact an individual's day-to-day activities. Simply implementing exercise into a daily routine and adapting to a healthier lifestyle can help improve limb function. However, lifestyle changes can only help so much. Therefore, devices such as the FlowOx™ can be recommended for patients with other comorbidities as they can be used at home and have proven to be beneficial for many patients. 

References:

  1. Peripheral artery disease (PAD) - Symptoms and causes [Internet]. Mayo Clinic. 2022 [cited 2 June 2022]. Available from: https://www.mayoclinic.org/diseases-conditions/peripheral-artery-disease/symptoms-causes/syc-20350557
  2. Peripheral arterial disease (PAD) [Internet]. nhs.uk. 2022 [cited 2 June 2022]. Available from: https://www.nhs.uk/conditions/peripheral-arterial-disease-pad/
  3. Kyle D, Boylan L, Wilson L, Haining S, Oates C, Sims A et al. Accuracy of Peripheral Arterial Disease Registers in UK General Practice: Case-Control Study. Journal of Primary Care & Community Health. 2020;11:215013272094614.
  4. Song P, Rudan D, Zhu Y, Fowkes F, Rahimi K, Fowkes F et al. Global, regional, and national prevalence and risk factors for peripheral artery disease in 2015: an updated systematic review and analysis. The Lancet Global Health. 2019;7(8):e1020-e1030.
  5. Wann-Hansson C, Wennick A. How do patients with peripheral arterial disease communicate their knowledge about their illness and treatments? A qualitative descriptive study.(report). BMC Nurs. 2016;15(1):29.
  6. Makris GC, Lattimer CR, Lavida A, Geroulakos G. Availability of supervised exercise programs and the role of structured home-based exercise in peripheral arterial disease. Eur J Vasc Endovasc Surg. 2012;44(6):569–75.
  7. Sedgwick et al., 2021 - Sedgwick C, Growcott C, Akhtar S, Parker D, Pettersen E, Hashmi F et al. Patient and clinician experiences and opinions of the use of a novel home use medical device in the treatment of peripheral vascular disease - a qualitative study. Journal of Foot and Ankle Research. 2021;14(1).
  8. Bergersen TK, Storheim E, Gundersen S, Kleven L, Johnson M, Sandvik L, et al. Improved clinical efficacy with wound support network between hospital and home care service. Adv Skin Wound Care. 2016;29(11):511–7.
  9. CV Physiology | Pressure Gradients [Internet]. Cvphysiology.com. 2022 [cited 3 June 2022]. Available from: https://www.cvphysiology.com/Hemodynamics/H010
  10. Gatenby A. Shear Rate - What is it?  Should You Care? All About Viscosity [Internet]. Cscscientific.com. 2022 [cited 3 June 2022]. Available from: https://www.cscscientific.com/csc-scientific-blog/shear-rate-what-is-it-should-you-care-all-about-viscosity
  11. Holder SM, Dawson EA, Brislane Á, Hisdal J, Green DJ, Thijssen DHJ. Fluctuation in shear rate, with unaltered mean shear rate, improves brachial artery flow-mediated dilation in healthy, young men. J Appl Physiol. 2019;126(6):1687–93.Hoel H, Pettersen EM, Høiseth LØ, Mathiesen I, Seternes A, Hisdal J. A randomized controlled trial of treatment with intermittent negative pressure for intermittent claudication. J Vasc Surg. 2020;73(5):1750–8.
  12. Hoel H, Pettersen EM, Høiseth LØ, Mathiesen I, Seternes A, Hisdal J. Lower extremity intermittent negative pressure for intermittent claudication. Follow-up after 24 weeks of treatment. Ann Vasc Surg. 2021;75:253.
  13. CE marking [Internet]. Internal Market, Industry, Entrepreneurship and SMEs. 2022 [cited 3 June 2022]. Available from: https://ec.europa.eu/growth/single-market/ce-marking_en 

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Murielle Nsiela

MSc Graduate in Medical Engineering - Bachelor's degree, Pharmaceutical Science, Keele University, Staffordshire UK

MSc in Medical Engineering Design, Keele University Modules included: Advanced engineering applications, Engineering for medical applications report, Bioreactors and Growth environment, Creative engineering design, Experimental research methodology and research projects



BSc (Hons) Pharmaceutical Science, Technology and Business, Keele University Modules included: Core topics in pharmaceutical science, Laboratory studies - tabletting and liposomes report, applied Pharmaceutical Science 2, Pharmaceutical research project

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