Phase 3 Study to Evaluate the Safety and Efficacy of Galnobax® in Treating Diabetic Foot Ulcers

Summary

The purpose of the current Study is to determine the safety and effectiveness of Galnobax® plus Standard of Care versus only Standard of Care, in treating Diabetic Foot Ulcers (DFU). In addition, Study is designed to investigate the safety of Galnobax® vehicle for establishing non-deleterious effects of Vehicle on wound healing in the Subjects with DFU. The study is being conducted in 350 subjects being recruited in about 30 centers in India.

Timeline

Start

2018-12-26

Primary completion

2021-08-19

Completion

2021-12-06

Publications

• Rastogi A, Kulkarni SA, Agarwal S, Akhtar M, Arsule S, Bhamre S, Bhosle D, Desai S, Deshmukh M, Giriraja KV, Jagannath J, Kashiva RY, Kesavan R, Khandelwal D, Kolte S, Kongara S, Darivemula AK, Madhusudan C, Pyare Saheb Qureshi MAH, Ramu M, Rathod G, Yalamanchi SR, Shakya S, Shetty P, Singh S, Deshpande SK, Viswanathan V, Unnikrishnan AG. Topical Esmolol Hydrochloride as a Novel Treatment Modality for Diabetic Foot Ulcers: A Phase 3 Randomized Clinical Trial. JAMA Netw Open. 2023 May 1;6(5):e2311509. doi: 10.1001/jamanetworkopen.2023.11509.

Drugs

Indications