TY - JOUR
T1 - Economic benefit of a novel dual-mode ambulatory compression device for treatment of chronic venous leg ulcers in a randomized clinical trial
AU - ACTitouch Investigators
AU - Marston, William A.
AU - Kirsner, Robert S.
AU - Tallis, Arthur
AU - Hanft, Jason R.
AU - Walters, Jodi
AU - Farber, Alik
AU - Cazzell, Shawn
AU - Comerota, Anthony
AU - Fish, John
AU - Frykberg, Robert
AU - Gordon, Ian
AU - Hanft, Jason
AU - Kirsner, Robert
AU - Nouvong, Aksone
AU - O'Connell, Jessica
AU - Snyder, Robert
AU - Vayser, Dean
N1 - Funding Information:
This work was funded by Tactile Medical, which developed the ACTitouch device studied in this clinical trial. Tactile Medical approved the study design and provided funding for the statistical analysis of the study data. Tactile Medical approved the decision to submit the manuscript for publication.Author conflict of interest: W.A.M. has been paid consulting fees by Tactile Medical in compensation for time in the design of the trial protocol and for service as principal investigator. W.A.M., R.S.K., A.T., J.R.H., J.W., and A.F. have received research funding from Tactile Medical for costs associated with performing the clinical trial reported in this article.
PY - 2020/11
Y1 - 2020/11
N2 - 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.
AB - 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.
KW - Clinical trial
KW - Compression therapy
KW - Venous insufficiency
KW - Venous ulcer
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U2 - 10.1016/j.jvsv.2020.03.004
DO - 10.1016/j.jvsv.2020.03.004
M3 - Article
C2 - 32451241
AN - SCOPUS:85085190341
VL - 8
SP - 1031-1040.e1
JO - Journal of Vascular Surgery: Venous and Lymphatic Disorders
JF - Journal of Vascular Surgery: Venous and Lymphatic Disorders
SN - 2213-333X
IS - 6
ER -