The Wound Express System, A Potential Treatment for Patients with Ulcers and Non-Operable Arterial Disease: A Pilot Safety Study

Abstract

Background: Intermittent pneumatic compression (IPC) devices apply intermittent compression to the thigh, which is thought to facilitate wound healing by improving wound perfusion in patients with chronic limb-threatening ischemia and no option for revascularization. Wound Express is an IPC device but its safety and efficacy are currently unclear. In this study, we aimed to determine the safety of the Wound Express IPC system in this high-risk cohort.Methods: This was a prospective, non-controlled, non-randomized pilot safety study. In total, 19 patients were screened for inclusion and 10 were recruited. IPC was applied for 2 hours per day for 12 weeks. The primary endpoint was any treatment-related adverse event in the first 3 months. Secondary endpoints included pain using the visual analogue scale, limb status assessed using the Wound, Ischemia, Foot Infection (WIFi) score and quality of life using the Vascular Quality of Life Questionnaire (VASUQOL) score.Results: Of the 10 patients who were enrolled, eight completed the 12-week course. There were no treatment-related adverse events. One patient died from coronavirus disease 19-related disease and two withdrew for reasons unrelated to treatment. Median pain scores were reduced from 6 to 0, while median VASUQOL increased from 10 to 16.5. WIFi scores were reduced in three out of eight of participants (37.5%).Conclusion: Wound Express appears to be safe and may decrease pain, improve wound healing and improve quality of life for chronic limb-threatening ischemia patients. Adequately powered, prospectively randomized trials of the Wound Express system to assess its efficacy and safety are warranted.