Healing and limb preservation with ON101 Topical Cream in chronic diabetic foot ulcers: an observational comparative study

Methods

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• Study & Design: Retrospective, observational study
• Sample Size: Total 57 patients with hard-to-heal DFUs
• Treatment protocol: Following adequate infection control and wound bed preparation, including debridement and/or re-vascularization as indicated. ON101 was applied once daily or by HCP’s instruction.
• Clinical Outcomes:
  ◆Complete Healing Rate
  ◆Mean Healing Time
  ◆Subgroup Analysis of Plantar patients

 

Patient Characteristic

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High-Risk Population Profile 82% of patients had diabetes duration >10 years
Common comorbidities included: Hypertension (HTN), Coronary artery disease (CAD) , Peripheral arterial occlusive disease (PAOD), Osteomyelitis (OM), End-stage renal disease (ESRD)

 

Flexible Pairing of ON101 with Multiple Secondary Dressing Types

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ON101 was paired with multiple secondary dressings based on wound status and exudate needs, demonstrating flexibility in routine DFU care.

 

Results / Discussion:

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◆Patients treated with ON101 achieved consistently higher complete healing rates than SOC, reaching 62% vs. 25% at Week 20 and 66% vs. 29% at Week 26.
◆Among healed patients, median healing time was substantially shorter with ON101 than SOC (74.9 vs. 176.8 days), suggesting accelerated wound closure.
◆Clinical benefit was also observed in challenging subgroups:
• Plantar ulcers: 80% vs. 20%
◆Importantly, these outcomes were achieved in a population with longstanding diabetes and multiple vascular/metabolic comorbidities.
◆No treatment-related adverse events were reported in the ON101 group.

 

 

Case Sharing

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Conclusion

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◆In this real-world observational comparative study, ON101 topical cream showed favorable healing outcomes in hard-to-heal chronic DFUs.
◆Despite longstanding diabetes, multiple comorbidities, and advanced wound severity, ON101-treated patients achieved higher complete healing rates and shorter median healing time than SOC.
◆Clinical benefit was also observed in challenging subgroup, such as plantar ulcers, supporting ON101 as a potential treatment option for difficult-to-manage DFUs.