Trial · NCT03998436

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

NCT03998436, Phase 3, Completed, Novalead Pharma Private Limited; results first posted 2023-09-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Phase 3 Study to Evaluate the Safety and Efficacy of Galnobax® in Treating Diabetic Foot Ulcers. Trials, record NCT03998436. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03998436

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Phase 3 Study to Evaluate the Safety and Efficacy of Galnobax® in Treating Diabetic Foot Ulcers
NCT number: NCT03998436
Status: Completed
Phases: Phase 3
Enrollment: 176 participants, actual
Lead sponsor: Novalead Pharma Private Limited
Conditions: Diabetic Foot Ulcer
Interventions: Esmolol Hydrochloride, Only Standard of Care, Vehicle Gel
First posted: 2019-06-26
Last updated: 2023-09-22
Results first posted: 2023-09-22

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Proportion of Subjects Achieving Target Ulcer Closure Within 12-week Treatment Phase, as Assessed by Blinded Investigator	Wound closure assessed up to week 12 and confirmed by 2 visits 2 weeks apart; only participants with wound closure at or before Week 12 and who maintained closure after 4-weeks of follow-up reported	Proportion of complete closure of wounds within 12-week treatment phase where Complete wound closure is defined as complete skin re-epithelialization that is without drainage or dressing requirements evaluated in two visits two weeks apart from first observation of closure.
Secondary	Proportion of Subjects Achieving Target Ulcer Closure Till End of Study, as Assessed by the Blinded Investigator.	24-weeks. The ulcers achieving complete closure till end of study	Proportion of complete closure of wounds at 24-weeks or End of Study where Complete wound closure is defined as complete skin re-epithelialization that is without drainage or dressing requirements.
Other	Proportion of Subjects With Treatment Emergent Adverse Events (TEAEs)	24-weeks	Proportion of Treatment emergent adverse events (TEAEs) in all the groups

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Proportion of Subjects Achieving Target Ulcer Closure Within 12-week Treatment Phase, as Assessed by Blinded Investigator	Wound closure assessed up to week 12 and confirmed by 2 visits 2 weeks apart; only participants with wound closure at or before Week 12 and who maintained closure after 4-weeks of follow-up reported	Subjects in FAS population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Proportion of Subjects Achieving Target Ulcer Closure Till End of Study, as Assessed by the Blinded Investigator.	24-weeks. The ulcers achieving complete closure till end of study		Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Proportion of Subjects With Treatment Emergent Adverse Events (TEAEs)	24-weeks	ITT (Safety population)	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group9

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Proportion of Subjects Achieving Target Ulcer Closure Within 12-week Treatment Phase, as Assessed by Blinded Investigator	Galnobax® 14% Gel Plus SoC	41	Participants
Proportion of Subjects Achieving Target Ulcer Closure Within 12-week Treatment Phase, as Assessed by Blinded Investigator	SoC Only	30	Participants
Proportion of Subjects Achieving Target Ulcer Closure Within 12-week Treatment Phase, as Assessed by Blinded Investigator	Vehicle Plus SoC	10	Participants
Proportion of Subjects Achieving Target Ulcer Closure Till End of Study, as Assessed by the Blinded Investigator.	Galnobax® 14% Gel Plus SoC	44	Participants
Proportion of Subjects Achieving Target Ulcer Closure Till End of Study, as Assessed by the Blinded Investigator.	SoC Only	35	Participants
Proportion of Subjects Achieving Target Ulcer Closure Till End of Study, as Assessed by the Blinded Investigator.	Vehicle Plus SoC	9	Participants
Proportion of Subjects With Treatment Emergent Adverse Events (TEAEs)	Galnobax® 14% Gel Plus SoC	10	Participants
Proportion of Subjects With Treatment Emergent Adverse Events (TEAEs)	SoC Only	14	Participants
Proportion of Subjects With Treatment Emergent Adverse Events (TEAEs)	Vehicle Plus SoC	9	Participants

Source ClinicalTrials.gov

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Galnobax® 14% Gel Plus SoC	76
Overall Study	STARTED	SoC Only	76
Overall Study	STARTED	Vehicle Plus SoC	24
Overall Study	COMPLETED	Galnobax® 14% Gel Plus SoC	68
Overall Study	COMPLETED	SoC Only	72
Overall Study	COMPLETED	Vehicle Plus SoC	23
Overall Study	NOT COMPLETED	Galnobax® 14% Gel Plus SoC	8
Overall Study	NOT COMPLETED	SoC Only	4
Overall Study	NOT COMPLETED	Vehicle Plus SoC	1

Source ClinicalTrials.gov

Adverse events51

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Cellulitis	Infections and infestations	Galnobax® 14% Gel Plus SoC	1	76	1
other	Cellulitis	Infections and infestations	SoC Only	2	76	2
other	Cellulitis	Infections and infestations	Vehicle Plus SoC	2	24	2
other	Wound infection	Infections and infestations	Galnobax® 14% Gel Plus SoC	1	76	1
other	Wound infection	Infections and infestations	SoC Only	0	76	0
other	Wound infection	Infections and infestations	Vehicle Plus SoC	1	24	1
other	Hypertension	Vascular disorders	Galnobax® 14% Gel Plus SoC	5	76	5
other	Hypertension	Vascular disorders	SoC Only	1	76	1
other	Hypertension	Vascular disorders	Vehicle Plus SoC	0	24	0
other	Acute kidney injury	Renal and urinary disorders	Galnobax® 14% Gel Plus SoC	1	76	1

1 to 10 of 51Source ClinicalTrials.gov

See all 51 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Galnobax® 14% Gel Plus SoC	0	76
Total, all-cause mortality	SoC Only	0	76
Total, all-cause mortality	Vehicle Plus SoC	1	24
Total, other adverse events	Galnobax® 14% Gel Plus SoC	9	76
Total, other adverse events	SoC Only	7	76
Total, other adverse events	Vehicle Plus SoC	9	24
Total, serious adverse events	Galnobax® 14% Gel Plus SoC	1	76
Total, serious adverse events	SoC Only	2	76
Total, serious adverse events	Vehicle Plus SoC	4	24

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
37184839	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03998436

GET https://conductscience.org/api/trials/v1/NCT03998436/events?page=2

API reference For AI assistants