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Novel Topical Esmolol Hydrochloride (Galnobax) for Diabetic Foot Wound: Phase 1/2, Multicenter, Randomized,
Ashu Rastogi1, Sudhir A Kulkarni2, Supreet K Deshpande2
1Department of Endocrinology, Post Graduate Institute of Medical Education and research (PGIMER), Chandigarh, India.
Advances in Wound Care
|October 17, 2022
Summary
Topical esmolol hydrochloride (Galnobax) shows promise for diabetic foot ulcer (DFU) healing. This study found minimal systemic absorption, indicating a safe treatment option for DFU patients.
Area of Science:
- Dermatology
- Endocrinology
- Pharmacology
Background:
- Diabetic foot ulcers (DFUs) are a significant complication of diabetes, often unresponsive to standard care.
- Novel therapeutic approaches are needed to improve DFU healing rates and reduce complications.
Purpose of the Study:
- To evaluate the safety and dose-finding efficacy of topical esmolol hydrochloride (Galnobax) for DFU healing.
- To assess systemic absorption and safety profile of esmolol hydrochloride in DFU patients.
Main Methods:
- Phase 1/2, multicenter, randomized, double-blind, vehicle-controlled study.
- Participants with Wagner grade I or II DFU received topical Galnobax (14% or 20%) or vehicle BID/OD.
- Primary endpoint: reduction in ulcer area and volume at week 12 or wound closure.
Main Results:
- Significant reductions in ulcer area and volume observed across treatment groups, with no statistically significant differences between Galnobax and vehicle (p=0.47 for area, p=0.86 for volume).
- Topical esmolol hydrochloride demonstrated minimal systemic absorption (esmolol concentration <10 ng/mL).
- No significant adverse events related to systemic esmolol were reported.
Conclusions:
- Topical esmolol hydrochloride (Galnobax) is a safe and potentially effective novel treatment for diabetic foot ulcers.
- Minimal systemic exposure suggests a favorable safety profile for DFU management.
