Venous Leg Ulcer Studies

ACTitouch Delivers Accurately Targeted and More Consistent Compression versus Multi-Layer Bandages

Authors: Mayrovitz HN, Partsch H, Vanscheidt W

Published: Journal of Wound, Ostomy & Continence Nursing September/October 2015

Purpose: To compare interface pressure profiles of ACTitouch therapy with traditional 4LB and compare the ability of each to sustain graduated compression over time.

Results: At 1 hour, the 4LB showed a significant (P < 0.001) decline in pressures while seated at all three pressure sites while ACTitouch pressures showed no decline. By hour 8 of device wear, the largest average seated pressure decrease for the 4LB occurred at site 2 and was 9.1 mmHg, while ACTitouch showed an increase of 4.9 mmHg at the same site.Conclusions: ACTitouch delivers a more consistent and predictable sustained interface pressure when compared to a 4LB. The 4LB demonstrated significant pressure loss.

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ACTitouch System Improves Quality of Life; High Adherence to Therapy and High Satisfaction in Patients with Venous Leg Ulcers

Authors: Keith G Harding, Wolfgang Vanscheidt, Hugo Partsch, Joseph A Caprini & Anthony J Comerota

Published: International Wound Journal May 2014

Purpose: Efficacy, functionality, safety, patient perceptions and impact on QoL were evaluated for ACTitouch adaptive compression therapy compared to a standard four-layer bandage (4-LB) (Profore™ Multi-Layer Bandaging System, Smith & Nephew Medical Wound Management, U.K.) for the treatment of patients with VLUs.

Results: Healing time and rates were comparable between the two groups. ACTtouch QoL index score was significantly higher than the index score for 4-LB with a statistically significant P value of 0.0375. Patients rated ACTitouch significantly higher than 4-LBs for exudate management, skin protection, removal ease, bathing and sleep comfort; other performance ratings were comparable between the two groups. Adverse events were comparable in type and frequency with no serious adverse events in either group.

Conclusions: ACTitouch is a safe and effective therapy that significantly improves patient QoL when compared with a traditional 4-LB. Given more control over their own therapy, patients are empowered to perform daily activities such as showering/bathing, and unencumbered sleep while engaging in an effective treatment regimen.

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Dose-response of compression therapy for chronic venous edema — higher pressures are associated with greater volume reduction: Two randomized clinical studies

Authors: Wolfgang Vanscheidt, MD, Alexandra Ukat, MD, and Hugo Partsch, MD

Published: Journal of Vascular Surgery, February 2009

Purpose: Evaluate the safety and relative effects of different cuff pressure combinations to determine if edema reduction was dose-dependent.

Results: A dose-response relationship was observed between increased SPC/IPC pressures and reduced limb edema. Limb volume was reduced most effectively with the highest pressures of 40-mm Hg nongraduated SPC and 60-mm Hg graduated IPC (136 mL and 87 mL, respectively); however, some subjects reported discomfort with these profiles. Limb volume was reduced by more than 100 mL with 30 to 40-mm Hg graduated SPC and by 69 mL with 50-mm Hg graduated IPC, and subjects rated these profiles as comfortable or very comfortable. Of the 28 study participants (12 SPC, 16 IPC), two subjects reported pain with 60-mm Hg IPC; no other adverse events were reported with SPC or IPC.

Conclusions: Pneumatic compression was safe and well-tolerated, with a dose-response relationship between increased SPC/IPC pressures and reduced leg edema. To our knowledge this is the first study to demonstrate a dose-relationship in compression therapy: higher pressures are associated with greater volume reduction in subjects with chronic venous edema.