International Wound Journal ISSN 1742-4801
ORIGINAL ARTICLE
Adaptive compression therapy for venous leg ulcers: a clinically effective, patient-centred approach Keith G Harding1 , Wolfgang Vanscheidt2 , Hugo Partsch3 , Joseph A Caprini4,5 & Anthony J Comerota6 1 Clinical Innovation, Welsh Wound Innovation Centre, Cardiff University School of Medicine, Cardiff, UK 2 Facharzt für Dermatologie Phebologie Allergologie, Freiburg, Germany 3 Department of Dermatology, Medical University of Vienna, Vienna, Austria 4 Division of Vascular Surgery, NorthShore University HealthSystem, Evanston, IL, USA 5 The University of Chicago Pritzker School of Medicine, Chicago, IL, USA 6 Jobst Vascular Institute, Toledo, OH, USA
Key words Adaptive compression therapy; Four-layer bandage; Pneumatic compression; Quality of life; Venous leg ulcer Correspondence to Prof. K G Harding, CBE Dean Clinical Innovation Welsh Wound Innovation Centre Cardiff University School of Medicine Upper Ground Floor, Room 18 Heath Park Cardiff CF14 4XN E-mail:
[email protected]
Harding KG, Vanscheidt W, Partsch H, Caprini JA, Comerota AJ. Adaptive compression therapy for venous leg ulcers: a clinically effective, patient-centred approach. Int Wound J 2014; doi: 10.1111/iwj.12292 Abstract A prospective, randomised, 12-week study was performed to evaluate the efficacy and tolerability of two compression methods for venous leg ulcers (VLUs); a new adaptive compression therapy (ACT) system, combining intermittent and sustained pneumatic compression (n = 38) and a conventional four-layer bandage system (n = 52). Primary outcomes were ulcer healing and safety. Secondary outcomes were comfort, compliance, ulcer pain, patient-perceived product performance and quality of life. Ulcer healing rate was similar (31⋅6% versus 42⋅3%, respectively, P = 0⋅30) between the treatments. Adverse events and patient-rated comfort were also similar. Average daily usage for the dual system was 10⋅5 and 1⋅8 hours in the sustained and intermittent modes, respectively, representing its use during 71% of waking hours. Predicted final ulcer pain was also similar (P = 0⋅68). Performance was subjectively better for adaptive compression and significantly higher for exudate management (P = 0⋅04), skin protection (P < 0⋅001), removal ease (P = 0⋅0007), bathing (P < 0⋅0001) and sleep comfort (P = 0⋅0405). The adjusted final quality-of-life score was 0⋅1025 higher for adaptive compression (P = 0⋅0375). Subjects with healed ulcers attained higher final scores than unhealed subjects (P = 0⋅0004). This study provides evidence that ACT is comparably efficacious to successfully heal VLUs compared with four-layer bandage management but is better accepted and achieves higher patient-reported quality-of-life scores in these challenging patients.
Introduction
Venous leg ulcers (VLUs) represent morbid clinical challenges, impair quality of life (QoL) and are costly. Clinically effective therapies that might lower the high morbidity and cost of VLU treatment therefore represent a need for key clinical care. Standard of care usually consists of local wound management combined with prescription of compression therapy. Compression is typically applied using bandages or stockings. In situations where patients are unable to apply high compression due to co-morbidities (e.g. arthritis, obesity and weakness), patient compliance is inevitably poor (1–4). Consequently, other therapeutic options have been sought to provide sufficient compression to the leg while supporting patient compliance.
Multi-component compression systems represent one of the key choices available to the clinician and VLU patient. The four-layer bandage system based on the original Charing Cross method (5,6) is often considered the gold
Key Messages • adaptive compression therapy is a combination of intermittent and sustained pneumatic compression • the dual principle of adaptive compression therapy and four-layer bandage compression therapy were equally effective in healing venous leg ulcers
© 2014 The Authors International Wound Journal © 2014 Medicalhelplines.com Inc and John Wiley & Sons Ltd doi: 10.1111/iwj.12292
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Dual-mode adaptive compression therapy for venous ulcers enhances patient-reported outcomes
Devices for Human Subjects, parts 1 and 2 (10). An ethics review was conducted by a duly sanctioned Ethics Committee in each of the countries in which the study was conducted. All participants provided written informed consent before study enrolment.
• product performance was rated higher in most categories for adaptive compression therapy. Superiority was demonstrated for exudate management, skin protection, removal ease, bathing and sleep comfort • adaptive compression therapy, permitting patients to remove the device for bathing and sleep, fosters preservation of a more normal lifestyle and was well accepted • a statistically greater improvement in quality of life was observed among patients receiving adaptive compression therapy as compared to use of four-layer bandage compression therapy
Study participants
standard of compression. However, multi-component compression bandage systems are also associated with significant limitations,(7) including inconsistency in application techniques, pressure loss, bulkiness, bandage slippage and decreased patient QoL. It has been recognised that improvements in VLU treatment might be achieved if effective compression could be prescribed, in association with preservation of patient-reported QoL and functional independence. A new device has been developed, which is capable of applying graded compression profiles similar to that produced by the Charing Cross four-layer bandage system, but which does not rely on the professional application of compression bandages. The adaptive compression therapy (ACT) device provides both controlled, sustained compression and intermittent pneumatic compression (IPC). The dual-mode functions are controlled by a microprocessor that links four pneumatic pressure cuffs while enabling different target pressures within each sequential cuff in the foot, ankle and calf. The device was designed to be easy to use and to thus encourage patient compliance with therapy as a key factor to support ulcer healing. The objective of this study was to evaluate efficacy, functionality, safety, patient perceptions and impact on QoL of this pneumatic compression device compared to a standard four-layer bandage system for the treatment of patients with VLUs. Methodology Study design
This was a prospective, stratified and randomised study comparing two methods of compression for the treatment of VLUs, an ACT device (ACTitouch, Tactile Medical, Minneapolis, MN) and a four-layer bandage system (4-LB) (Profore™ Multi-Layer Bandaging System, Smith & Nephew Medical Wound Management, Hull). Ethical considerations
This study conformed to the ethical guidelines of the Declaration of Helsinki as amended, October 2008 (8). The study was conducted in compliance with the Good Clinical Practice guidelines (9) and ISO 14155:2003 Clinical Investigation of Medical 2
K. G. Harding et al.
All subjects were outpatients over 18 years of age, were willing and able to wear the compression and follow the clinical study plan. Study inclusion required an ankle brachial pressure index (ABPI) of ≥ 0⋅8 and at least one VLU ≥2 cm2 in size but ≤15 cm in any one dimension, treated by compression therapy. All patients had a Duplex investigation to determine anatomic classification (Table 1). Exclusion criteria included skin sensitivity to any of the compressive components, participation in any clinical study within the previous 3 months, episode of deep vein thrombosis within the previous 3 months or leg circumferences that exceeded the fit range of the device. Patients with diabetes were excluded if there was inadequate metabolic control, if the patient had a history of blood sugar-related hospitalisation within the last 6 months or had diabetic foot lesions.
Study treatments
The ACT is a low-voltage device operated from a battery or electrical adaptor (Figure 1). The device uses pneumatic technology to apply controlled gradient compression to the lower leg. It consists of a foot and ankle cuff, a calf cuff and an electronic control unit. The cuffs are linked together to form one complete functional sleeve. The control unit clips into the sleeve for normal operation but can be removed by the healthcare professional to access treatment compliance data. The device is used in conjunction with an associated undersock (Figures 1 and 2). Three layers of materials are bonded together to form the sleeve with the inner and mid layers consisting of polyurethane material to form the inflatable elements and an outer cover layer consisting of highly durable polyurethane-coated nylon. The sock is knitted from a blend of cotton, polyester and nylon fibres and provides padding and moisture wicking properties. There are four separate bladders within the calf cuff that allow different pressures to be applied independently to the upper, mid and lower areas of the calf. The lower calf cuff is linked pneumatically to the ankle region to ensure that the same pressure level is applied throughout the region. The pressure is controlled using pressure transducers in the pneumatic supply system. The device design allows for subject mobility during use in the sustained compression mode and is therefore powered by a lightweight rechargeable battery. When the device is used in the IPC mode or is being recharged, it is powered by a plug-in power adaptor (Figure 1). The device was designed to provide graded compression when operated in the sustained mode, supplemented by intermittent compression for up to 2 hours per day when operated in the IPC mode. The sustained compression mode provides graded compression of 40 mmHg at the foot and ankle, 30 mmHg mid-calf and
© 2014 The Authors International Wound Journal © 2014 Medicalhelplines.com Inc and John Wiley & Sons Ltd
K. G. Harding et al.
Dual-mode adaptive compression therapy for venous ulcers enhances patient-reported outcomes
Table 1 Demographics and baseline ulcer characteristics Characteristic
4-LB
Gender Male 29 (56%) Female 23 (44%) Age Mean (SD) 62⋅6 (15⋅41) Ulcer location Foot 1 (2%) Ankle 20 (39%) Calf 12 (23%) Gaiter 19 (37%) Duration of ulcer (years) Mean (SD) 2⋅57 (4⋅84) Ulcer size (cm2 ) Mean (SD) 14⋅18 (15⋅15) Ulcer depth Superficial 17 (33%) Shallow 32 (62%) Deep 3 (6%) Level of exudate None 1 (2%) Mild 19 (37%) Moderate 26 (50%) Heavy 6 (12%) (missing) 0 Level of oedema Minimal 32 (62%) Moderate 16 (31%) Considerable 4 (8%) Odour with pre-study dressing in place None 33 (64%) Faint 11 (21%) Moderate 7 (14%) Strong 1 (2%) ABPI Mean (SD) 1⋅15 (0⋅18) Anatomic classification Superficial 21 (41%) Deep 15 (29%) Perforator 4 (8%) Superficial/perforator 2 (4%) Superficial/deep 2 (4%) Superficial/deep/perforator 6 (12%) Deep/perforator 1 (2%) (missing) 1 (2%) Ulcer stratification
