Economic benefit of a novel dual-mode ambulatory compression device for treatment of chronic venous leg ulcers in a randomized clinical trial

J Vasc Surg Venous Lymphat Disord. 2020 Nov;8(6):1031-1040.e1. doi: 10.1016/j.jvsv.2020.03.004. Epub 2020 May 22.


Background: Limb compression is a key component of protocols used to heal venous leg ulcers (VLUs). A novel ambulatory pneumatic compression device was tested in comparison with multilayered bandage (MLB) compression systems for the treatment of VLUs in a prospective randomized clinical trial.

Methods: Patients with VLUs measuring 1.5 to 50 cm2 with duration of 1 to 24 months were randomized to treatment with a pneumatic compression device, the ACTitouch adaptive compression therapy (ACT) system (Tactile Medical, Minneapolis, Minn), or MLB. The ACT group patients were seen in the clinic at weeks 1, 2, 4, 6, 9, 12, and 16 or until wounds healed; the MLB group was seen weekly for bandage and dressing changes for 16 weeks or until wounds healed. All other aspects of VLU care were standardized between the two groups. The primary study objective was to compare the VLU percentage area reduction at 16 weeks in the ACT group compared with the MLB group.

Results: There were 56 patients randomized to treatment with ACT (n = 26) or MLB (n = 30). In the ACT group, five patients exited because of skin or wound problems related to the ACT device and five withdrew because of the inconvenience of using the device. Therefore, the trial was halted before full randomization so improvements to the ACT device could be made. Data collected on 42 patients who were able to tolerate treatment for the 16-week study period (per protocol group) showed that both groups experienced similar rates of wound healing. In the per protocol population, the percentage area size reduction was greater for the ACT group compared with the MLB group (83.8% vs 70.5%, respectively), whereas no significant differences were noted in the percentage of wounds that healed by 16 weeks (60.0% vs 63.0%, respectively).

Conclusions: In this truncated clinical trial, a novel dual-mode ambulatory compression device, when tolerated, achieved wound healing results similar to those with MLB for chronic VLUs. The device requires modifications to improve the patient's comfort and ease of use. However, this mode of therapy appears to have promise for improving the cost-effectiveness of treatment for chronic VLUs.

Trial registration: NCT02680834.

Keywords: Clinical trial; Compression therapy; Venous insufficiency; Venous ulcer.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Chronic Disease
  • Compression Bandages / adverse effects
  • Compression Bandages / economics*
  • Cost-Benefit Analysis
  • Female
  • Health Care Costs*
  • Humans
  • Intermittent Pneumatic Compression Devices / adverse effects
  • Intermittent Pneumatic Compression Devices / economics*
  • Male
  • Middle Aged
  • Prospective Studies
  • Time Factors
  • Treatment Outcome
  • United States
  • Varicose Ulcer / diagnostic imaging
  • Varicose Ulcer / economics*
  • Varicose Ulcer / physiopathology
  • Varicose Ulcer / therapy*
  • Venous Insufficiency / diagnostic imaging
  • Venous Insufficiency / economics*
  • Venous Insufficiency / physiopathology
  • Venous Insufficiency / therapy*
  • Wound Healing*

Associated data