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Clinical Investigation of Galnobax® for the Treatment of Diabetic Foot Ulcers

NCT01113515 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2024-05-20

Study results available
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Summary

The purpose of this study is to determine safety and efficacy of a new gel formulation of Esmolol hydrochloride (Galnobax®) for the treatment of Diabetic Foot Ulcer (DFU). The study will compare number and types of adverse events occured, rates of wound closure and percentage of wounds closed in Galnobax treated groups versus placebo group.

Conditions

  • Diabetic Foot Ulcer

Interventions

DRUG

Esmolol hydrochloride

DRUG

Esmolol hydrochloride

DRUG

Esmolol hydrochloride

DRUG

Placebo gel

Sponsors & Collaborators

  • Novalead Pharma Private Limited

    lead INDUSTRY

Principal Investigators

  • Vickie R Driver, DPM FACFAS · Providence Veteran Affairs Medical Center, RI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-02-20
Primary Completion
2015-06-27
Completion
2015-10-17

Countries

  • United States
  • India
  • Malaysia

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 NCT01113515 on ClinicalTrials.gov