Real-World Effectiveness of ON101 Topical Cream in Venous Leg Ulcer Management: A Multinational Retrospective Study

Methods

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• Study & Design: Retrospective, single-arm, real-world study
• Sample Size: 10 patients with chronic VLUs
• Site: United States, India, and Egypt
• CEAP Class: CEAP class C6 and C6R
• Ulcer Size (median): 7.5 cm² (ON101) vs. 6.2 cm² (SOC)
• Treatment Protocol: Patients received topical ON101 for up to 16 weeks, combined with
  venous hypertension management provided by HCPs according to routine clinical practice and
  each patient’s individual condition. Interventions such as grade 3 compression stockings,
  venous surgery, or perforator ligation were used as appropriate based on ulcer severity.
• Comparator: historical standard-of-care (SOC) data*

Results / Discussion:

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Eighty percent of patients achieved complete healing within 16 weeks, compared to 39% reported with SOC (p=0.0344). Median time to complete healing was 26.5 days, substantially shorter than the 90–180 days typically observed with SOC. Healing rates were consistently high across countries, with the USA showing completion in 3–13 weeks over 3–13 visits, India achieving healing in 6 weeks with 2 visits, and Egypt in 1–2 weeks with a single visit. No adverse events were reported, indicating an excellent safety profile.

Result

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ON101 topical cream showed rapid and safe healing performance in the treatment of VLUs after the correction of venous hypertension across diverse real-world settings. Its use was associated with reduced healing time and fewer clinical visits, supporting its role as an effective and practical option for VLU management in global wound care practice.