RESUMO
Objective: This study compared the effect of two frequencies of direct cold atmospheric plasma (direct-CAP) treatment with standard of care (SOC) alone on healing of venous leg ulcers (VLUs). Approach: Open-label, randomized controlled trial (ClinicalTrials.gov NCT04922463) on chronic VLUs at two home care organizations in the Netherlands. All three groups received SOC for 12 weeks or until healing. In addition, treatment groups received direct-CAP once (1× direct-CAP) or twice (2× direct-CAP) a week, at specialized wound care facilities and the patients' residences. Primary outcome was percentage of wounds healed. Secondary outcomes included wound area reduction and adverse events. Results: In total, 46 patients were randomly allocated to receive SOC only (n = 15), SOC + direct-CAP once a week (n = 17), or SOC + direct-CAP twice a week (n = 14). A higher percentage of wounds healed within 12 weeks in the treatment groups 53.3% (1× direct-CAP, p = 0.16) and 61.5% (2× direct-CAP, p = 0.08) versus 25.0% (control). The largest wound area reduction was obtained with 2× direct-CAP (95.2%, p = 0.07), followed by 1× direct-CAP (63.9%, p = 0.58), versus control (52.8%). Absolute wound area reduced significantly compared with baseline in both treatment groups (p ≤ 0.001), not in control (p = 0.11). No device-related serious adverse events occurred. Innovation: Direct-CAP applied once or twice a week could substantially improve wound healing of VLUs in primary care. Conclusion: Together with other clinical safety and efficacy data, these results support the integration of direct-CAP as a valuable therapy for complex wounds.
