Economic Benefit of a Novel Dual Mode Ambulatory Compression Device for Treatment of Chronic Venous Leg Ulcers

Abstract

Compression is critical to heal chronic venous leg ulcers (VLUs). A novel dual mode ambulatory pneumatic compression (APC) device was tested in comparison to multilayered compression bandaging systems for the treatment of nonhealing VLUs in a prospective randomized clinical trial (RCT). Patients with VLUs measuring between 2 and 50 cm2 present for 1 to 12 months were randomized to treatment with the APC device (ACT group; Actitouch; Tactile Medical, Minneapolis, Minn] or multilayered compression bandaging (MLB) with either Profore (Smith & Nephew, Memphis, Tenn) or Coban 2 (3M Health Care, St. Paul, Minn) compression systems. Patients in the ACT group were asked to wear the device for sustained or intermittent compression throughout the day and to wear a light compression stocking at night. The ACT group patients were seen every 2 to 3 weeks for follow-up to 16 weeks, allowing more in-home care. The MLB group was seen in the outpatient clinic weekly. Other aspects of VLU care were standardized between the two groups. The primary study objective was to compare wound size reduction at 16 weeks between the two groups in a noninferiority RCT. Secondary objectives assessed the effect of each therapy on medical resource utilization and the direct cost of care. There were 58 patients who were randomized to treatment with either MLB (n = 30) or ACT (n=28). Both groups experienced similar rates of wound healing during the 16-week follow-up period, with ACT group patients decreasing from 4.01 ± 2.4 cm2 to 1.21 ± 2.5 cm2 and MLB-treated wounds decreasing from 7.6 ± 7.9 cm2 to 2.5 ± 6.1 cm2. There was no significant difference between groups in percentage of wound closure, incidence of complete wound healing, or improvement in Venous Clinical Severity Score. ACT-treated wounds had lower utilization of non-study-related clinic visits compared with the MLB cohort (50.0% vs 63.3%, respectively). In addition, there were fewer ACT-scheduled patient visits without any associated complications, resulting in lower direct medical costs compared with the MLB cohort (− difference [−$2733; P = .06]). The trial was halted before full randomization to make improvements to the ACT device to increase the patient’s comfort and usability, as suggested by both participating physicians and patients. In this preliminary RCT, a novel APC device achieved similar VLU wound healing results in comparison to MLB but with lower direct costs. The study has led to important changes in device design that will allow confirmation of these findings in a larger RCT.