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Beta Blocker

Galnobax 20% BID for Foot Ulcer

Phase 1 & 2
Waitlist Available
Led By Vickie R Driver, DPM FACFAS
Research Sponsored by Novalead Pharma Private Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and end of treatment (week 12 or 84 +/- 2 days)
Awards & highlights
All Individual Drugs Already Approved

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.

Eligible Conditions
  • Foot Ulcer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and end of treatment (week 12 or 84 +/- 2 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and end of treatment (week 12 or 84 +/- 2 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety Outcome
Secondary study objectives
Efficacy Outcome
Other study objectives
Pharmacokinetic Measurements

Side effects data

From 2015 Phase 1 & 2 trial • 44 Patients • NCT01113515
18%
Skin discoloration
9%
Pyrexia
9%
Inflammation
9%
Excoriation
9%
Local swelling
100%
80%
60%
40%
20%
0%
Study treatment Arm
Galnobax 14% BID
Placebo
Galnobax 20% QD
Galnobax 20% BID

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Galnobax 20% QDExperimental Treatment1 Intervention
Esmolol Hydrochloride (Galnobax) 20% gel once daily
Group II: Galnobax 20% BIDExperimental Treatment1 Intervention
Esmolol Hydrochloride (Galnobax) 20% gel twice daily
Group III: Galnobax 14% BIDExperimental Treatment1 Intervention
Esmolol Hydrochloride (Galnobax) 14% gel twice daily
Group IV: PlaceboPlacebo Group1 Intervention
Placebo gel
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Esmolol
FDA approved

Find a Location

Who is running the clinical trial?

Novalead Pharma Private LimitedLead Sponsor
1 Previous Clinical Trials
176 Total Patients Enrolled
1 Trials studying Foot Ulcer
176 Patients Enrolled for Foot Ulcer
Vickie R Driver, DPM FACFASPrincipal InvestigatorProvidence Veteran Affairs Medical Center, RI
~4 spots leftby Oct 2025
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