by Sarah Yonak
Venous leg ulcers (VLUs) make up 80% of lower extremity ulcers. These ulcers can persist for lengthy periods of time and are often recurring.1 Many clinicians find themselves frustrated with this common, and often persistent, symptom of chronic venous insufficiency (CVI). Common as they are, available treatment options, such as multi-component compression bandage systems, are associated with significant limitations, including inconsistency in application techniques, pressure loss, bulkiness, slippage and decreased patient quality of life.2 These limitations pose serious barriers for both clinicians and patients suffering from VLUs. Protocols utilizing multi-layer bandages and zinc gauze wraps are deeply ingrained within most specialty wound care clinics, but with decreasing reimbursement and increasing pressure to report positive wound healing metrics, the challenges of these treatments have become more important to address. With an estimated cost burden of $2 billion in the United States,1 innovative treatment options for VLUs should be considered.
In a recent report from the International Compression Club, it was acknowledged that unless a therapy is welltolerated, compliance cannot be maximized. For therapy to be effective, compliance must be encouraged with the following six recommendations to meet patient needs:3
- Easy to wear and use. Patients should be able to self-apply the treatment at home
- Adjustable to accommodate a range of sizes and fluctuations in size
- Capable of being cleaned. Compression material must be able to be cleaned thoroughly and disinfected
- Portable and quiet
With these points in mind, key wound care physicians partnered with industry to develop a new technology for the treatment of VLUs. Looking critically at the challenges they faced on a daily basis, they pioneered a VLU treatment technology in a way that addresses many of the current challenges with compression. From that significant collaboration, the ACTitouch® Adaptive Compression Therapy system was born and is now available for the treatment of chronic venous insufficiency and VLUs.
The ACTitouch Device
The ACTitouch consists of a nylon wrap with four pneumatic chambers that inflate to provide two compression therapy options: an intermittent pneumatic compression mode and a sustained compression mode. The device is easily donned by the patient in minutes, using hook and loop closure. It is also self-contained with a battery and pneumatic pump integrated into the wrap, allowing patients to remain active even while the device is in use. A moisture-wicking sock is worn over the primary wound dressing. Since the device is easily self-applied and removed, patients are able to remove it for wound dressing changes, bathing and sleeping, as desired. The ACTitouch is also discrete and can be worn under regular clothes and shoes.
Clinical studies have shown the benefit of combining both intermittent pneumatic compression (IPC) and sustained compression to improve and accelerate venous ulcer healing.4,5,6 One study noted that patients using IPC in conjunction with sustained compression, experienced not only better wound healing rates, but significant reduction in edema and pain.7 Despite clinical evidence demonstrating the value of IPC in VLU healing, broad patient use has not been adopted due to limitations in day-to-day practical use. ACTitouch combines both of these proven therapies in a single, easy-to-apply ambulatory device. The IPC mode offers a sequential, graduated pressure profile that can be used for up to two hours each day. The dual functionality of the device means that in addition to the IPC mode, the device also provides the clinically necessary sustained compression for patients to use during their remaining wakeful hours. The sustained application is completely ambulatory, supporting patient activity, and may be worn as their primary form of compression versus multi-component bandaging.
The role and value of sustained compression in the treatment of VLUs is widely acknowledged as standard of care. While current therapies are designed to provide this compression, studies show that compression from multi-component bandages is not an ideal solution. It is well-documented in the literature that pressure loss starts immediately after application and a mean pressure loss of 30% occurs within seven days of application.8,9 Furthermore, achieving compression profiles within a therapeuticallyintended range from multi-component bandages, is timeconsuming and largely technique-dependent. In addition, practitioners do not have the capability to measure interface pressures in day-to-day practice to ensure target pressures were achieved upon application.
During the development phase of this new technology, it became apparent that the ideal compression therapy would be capable of adapting and adjusting to the patient’s dynamic needs over time to ensure consistent pressure. The ACTitouch utilizes a microprocessor with integrated sensors to automatically monitor and adjust interface pressure every 30 minutes to maintain pre-set target pressures throughout the day. This “smart device” ensures the patient receives the desired pressure profile even with normal fluctuations in the lower extremity, such as those that occur after hours of application, during periods of ambulation and rest, and as edema reduces.
Patient Compliance and Quality of Life
No matter how clinically effective a treatment may be, if the patient is not using it, or symptoms and/or perceived quality of life are not improved, the likelihood of benefiting from the treatment is diminished. Adherence is impacted by many factors, including device comfort and how the device fits with the patient’s usual daily activities. It is here that a recent clinical study comparing ACTitouch to a standard four-layer bandage was shown to excel. This randomized controlled trial demonstrated a statistically significant improvement in quality of life for ACTitouch users.10 Specifically, statistically significant superiority over four-layer bandages was reported in the areas of exudate management, skin protection, removal ease, and showering and bathing. The study concluded that given comparable healing rates, ACTitouch was better accepted by patients, as it empowers them with more control over their own therapy and rewards them with better quality of life.
Another important feature for clinicians is the built-in compliance tracker, which allows the option to monitor adherence to therapy with the ACTitouch device. The tracker will calculate an average number of hours each therapy mode was used. Even with additional freedom to don and doff the device at will, strong patient usage was documented, with patients wearing the device for a daily mean time of 10.54 hours in the sustained compression mode and 1.76 hours in the intermittent pneumatic compression mode.
The Next Generation is Here
After decades of minimal advances in VLU compression therapy, the next generation has finally arrived, providing a patient-centered treatment option for compression therapy.
1. Moffatt C, Kommala D, Dourdin N, Choe Y. Venous leg ulcers: patient concordance with compression therapy and its impact on healing and prevention of recurrence. Int Wound J. 2009;6(5):386–393.
2. Moffatt CJ, Edwards L, Collier M, Treadwell T, Miller M, Shafer L, Sibbald G, Brassard A, McIntosh A, Reyzelman A, Price P, Kraus SM, Walters SA, Harding K. A randomised controlled 8-week crossover clinical evaluation of the 3M Coban 2 Layer Compression System versus Profore to evaluate the product performance in patients with venous leg ulcers. Int Wound J 2008;5:267–79.
3. Delos Reyes A, Partsch H, Mosti G, Obi A, Lurie F. Report from the 2013 meeting of the International Compression Club on advances and challenges of compression therapy. Journal of Vascular Surgery: Venous and Lymphatic Disorders 24 March 2014 (Article in Press DOI: 10.1016/j.jvsv.2014.02.006)
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5. Comerota AJ. Intermittent pneumatic compression: physiologic and clinical basis to improve management of venous leg ulcers. J Vasc Surg. 2011;53(4):1121–1129.
6. Smith PC, Sarin S, Hasty J, Scurr J. Sequential gradient pneumatic compression enhances venous ulcer healing: a randomized trial. Surgery. 1990;108(5):871–875.
7. Lullove E, Alvarez O. Results of an Observational Longitudinal Retrospective Study. VEIN. Volume 7 Issue 1 Winter 2014: 38-42
8. Mosti G, Partsch H. Inelastic bandages maintain their hemodynamic effectiveness over time despite significant pressure loss. Journal of Vascular Surgery 2014;52(4)925-931.
9. Partsch H, Mosti G. Pressure-time integral of elastic versus inelastic bandages: practical implications. EWMA J 2013;13:15-7
10. Harding KG, Vanscheidt W, Partsch H, Caprini JA, Comerota AJ. Adaptive compression therapy for venous leg ulcers: a clinically effective, patient-centered approach. Int Wound J 2014; doi: 10.000/iwj.12292