Real-world effectiveness of ON101 topical cream in venous leg ulcer management : a multinational retrospective study

Case summary and Methods

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• Study & Design: Retrospective, single-arm real-world study
• Sample Size: 10 patients with chronic VLUs
• Sites: United States, India, Egypt
• Treatment Protocol:
  • ON101 applied twice daily for up to 16 weeks
  • Pre-treatment: Correction of venous hypertension(elastic stockings, surgery, or perforator ligation
    as appropriate)
• Comparator: Historical Standard of Care (SOC) data
• Outcomes:
  • Healing rate within 16 weeks
  • Healing time
  • Safety
  • Outpatient burden (clinic visits)

 

Results

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This retrospective, single-arm study included 10 patients with chronic VLUs treated with ON101 twice daily for up to 16 weeks (after correction of venous hypertension using various methods according to severity and etiology, including elastic stockings, venous surgery, or ulcer bed perforator ligation) at clinical sites in the United States, India, and Egypt. Healing outcomes were compared with historical Standard of Care (SOC) data. Safety was monitored throughout treatment. 5/10 wounds had been stalled for ≥ 20 weeks (one as long as 144 weeks) — all healed or showed marked size reduction during ON101 treatment.

 

Conclusion

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ON101 topical cream facilitated fast and safe healing of venous leg ulcers across real-world international
settings. Its benefits include:

• Rapid healing performance following venous correction
• Consistent safety profile across all treatment sites
• Shortened healing time and reduced outpatient burden, lowering visit frequency
• Effective outcomes even in regions with varying standards of venous hypertension control
• Compatible with Standard of Care (SOC) for venous hypertension correction using various methods including elastic stockings, venous surgery, or ulcer bed perforator ligation