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

NCT03998436 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2023-09-22

Study results available
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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.

Conditions

  • Diabetic Foot Ulcer

Interventions

DRUG

Esmolol Hydrochloride

Galnobax-14% gel application along with Standard of Care

OTHER

Only Standard of Care

Only Standard of Care treatment

OTHER

Vehicle Gel

Vehicle gel application along with Standard of Care

Sponsors & Collaborators

  • Novalead Pharma Private Limited

    lead INDUSTRY

Principal Investigators

  • Ashu Rastogi, MD · Post Graduate Institute of Medical Education and Research, Chandigarh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-26
Primary Completion
2021-08-19
Completion
2021-12-06
FDA Drug
Yes

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03998436 on ClinicalTrials.gov