Safety and Effectiveness of Negative Pressure Wound Therapy (Avelle) on Venous Leg Ulcers: The SPACE Study.

Introduction Hard-to-heal wounds represent a substantial burden on patients' quality of life and healthcare systems. Negative pressure wound therapy (NPWT) is an advanced therapy used to manage hard-to-heal wounds as an adjunct to standard wound care; however, there are limited data on its clinical effectiveness. The aim of this study was to evaluate the clinical effectiveness and safety of the Avelle NPWT system in hard-to-heal venous leg ulcers (VLUs). Methods This was a single-arm, single-center, open-label, prospective study (NCT05666570) conducted in a Colombian outpatient setting. Patients with a venous ulcer, as per Clinical, Etiological, Anatomical, and Pathophysiological (CEAP) Classification C6/C6R, that has not progressed by >30% in the previous 4 weeks were enrolled. Eligible patients received NPWT at the screening/baseline visit (Visit 1) with scheduled follow-up visits on Day 6 ± 1 (Visit 2) and Day 13 ± 1 (Visit 3; end of study). The primary endpoints were baseline change in wound size and dressing durability. Secondary endpoints included clinical wound characteristics and device-related adverse events. Results Fifty-nine patients (median age: 66 years) with VLUs were enrolled (intention-to-treat population). In the per protocol population (n=50), the mean ± standard deviation wound area was 13.4 ± 17.0 cm