Efficacy and safety of ON101 Topical cream for diabetic foot ulcers: a multinational centers real-world study on limb salvage & fast healing

Methods

  • Design: Retrospective single-arm observational study
  • Population: 42 patients with chronic DFUs
  • Sites: 6 clinics across USA, India, and Egypt
  • Treatment:
    • ON101 applied twice daily for up to 16 weeks
    • Etiological factors managed concomitantly (e.g., offloading, debridement, glycemic control)
  • Outcome Metrics:
    • Pain level
    • Erythema
    • Wound morphology and exudate changes
    • Patient-reported quality of life
Executive Summary

This multinational real-world study confirms that ON101 has broad effectiveness even in difficult to manage subgroups (e.g., patients with high HbA1C, large ulcers or plantar ulcers, etc.), with the following positive results:

  • Reduced healing time up to 62%
  • Reduced more than 50% of clinic visits per week
  • Home care and easy to use
  • Robust clinical outcome in various clinical setting

 

Conclusion


ON101 demonstrated high healing rates, faster wound resolution, and excellent safety in the treatment of DFUs across varied healthcare settings. The reduced number of clinic visits highlight ON101’s clinical and economic value. These findings support ON101 as a promising global option for DFU management and re-admission prevention.

 

Conference PublicationSAWC Fall 2025
Date Published3 de septiembrerd, 2025
AuthorsProf. Mohamed Sharkawy, MD, PhD1; Dr. Sanjay Sharma2; Dr. Vadim Glukh3; Dr. Narendranadh Meda4; Dr. Rajesh Kesavan5; Dr. Brock Liden, DPM6
Authors Information1. Cairo University Hospital, Egypt 2. Apta FootSecure, India 3. North Eastern Ohio Podiatry Group, US 4. Krishna Institure of Medical Sciences, India 5. Dr. RK Diabetic Foot and Podiatry Institute & Rakesh Jhunjhunwala Amputation Prevention Center, India 6. Cutting Edge Research LLC, US
Poster Presentation

Efficacy and safety of ON101 Topical cream for diabetic foot ulcers: a multinational centers real-world study on limb salvage & fast healing

Introduction

Diabetic foot ulcers (DFUs) are among the most serious complications of diabetes, often associated with delayed healing, infection, high rate of limb loss, and frequent hospital re-admissions. ON101 is a topical medical device formulated to support wound healing by promoting fast painless tissue healing process in a adequate wound environment. This multinational, real-world study assessed ON101’s clinical effectiveness , safety and lower morbidity and frequency of hospital re-admissions across diverse healthcare settings in the United States, India, and Egypt.