Trial · NCT01113515

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

NCT01113515, Phase 1, Phase 2, Completed, Novalead Pharma Private Limited; results first posted 2024-05-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Clinical Investigation of Galnobax® for the Treatment of Diabetic Foot Ulcers. Trials, record NCT01113515. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01113515

On this page

Trial

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

Title: Clinical Investigation of Galnobax® for the Treatment of Diabetic Foot Ulcers
NCT number: NCT01113515
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 44 participants, actual
Lead sponsor: Novalead Pharma Private Limited
Conditions: Diabetic Foot Ulcer
Interventions: Esmolol hydrochloride, Esmolol hydrochloride, Esmolol hydrochloride, Placebo gel
First posted: 2010-04-30
Last updated: 2024-05-20
Results first posted: 2024-05-20

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Safety Outcome	Till end of follow up period (Week 25)	Number of participant with adverse events (AEs) till end of follow-up phase in different groups
Secondary	Efficacy Outcome	Baseline and end of treatment (Week 12 or 84 +/- 2 days)	To evaluate the percent change in ulcer area and ulcer volume from baseline till end of treatment (Week 12) in different groups
Secondary	Efficacy Outcome	From baseline till end of treatment (Week 12 or 84 +/- 2 days)	Time in days taken for closure of wound in different groups from baseline till end of treatment (week 12 or 84 +/- 2 days)
Other	Pharmacokinetic Measurements	pre-dose (prior to first study drug application), and at 15 and 30 minutes, 1, 3, 6, 12, and 24 hours after the first study drug application on day 0, weeks 1, 4, and 12 (prior to study drug application).	Pharmacokinetic profile of Galnobax® in subset of patients suffering from DFU

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Safety Outcome	Till end of follow up period (Week 25)	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Efficacy Outcome	Baseline and end of treatment (Week 12 or 84 +/- 2 days)	percent change	MEAN
SECONDARY	Efficacy Outcome	From baseline till end of treatment (Week 12 or 84 +/- 2 days)	days	MEDIAN
OTHER_PRE_SPECIFIED	Pharmacokinetic Measurements	pre-dose (prior to first study drug application), and at 15 and 30 minutes, 1, 3, 6, 12, and 24 hours after the first study drug application on day 0, weeks 1, 4, and 12 (prior to study drug application).	Cmax (ng/mL) of Esmolol acid	MEAN

Source ClinicalTrials.gov

Results by group20

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

Outcome	Group	Category	Value	Spread	Units
Safety Outcome	Placebo		1		Participants
Safety Outcome	Galnobax 20% QD		3		Participants
Safety Outcome	Galnobax 20% BID		9		Participants
Safety Outcome	Galnobax 14% BID		6		Participants
Efficacy Outcome	Placebo	Percent Change in Ulcer Area	80.67	Standard Deviation 34.09	percent change
Efficacy Outcome	Galnobax 20% QD	Percent Change in Ulcer Area	82.58	Standard Deviation 31.57	percent change
Efficacy Outcome	Galnobax 20% BID	Percent Change in Ulcer Area	95.80	Standard Deviation 9.85	percent change
Efficacy Outcome	Galnobax 14% BID	Percent Change in Ulcer Area	86.56	Standard Deviation 35.07	percent change
Efficacy Outcome	Placebo	Percent Change in Ulcer Volume	84.57	Standard Deviation 32.99	percent change
Efficacy Outcome	Galnobax 20% QD	Percent Change in Ulcer Volume	55.41	Standard Deviation 92.31	percent change

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	10
Overall Study	STARTED	Galnobax 20% QD	9
Overall Study	STARTED	Galnobax 20% BID	14
Overall Study	STARTED	Galnobax 14% BID	11
Overall Study	COMPLETED	Placebo	10
Overall Study	COMPLETED	Galnobax 20% QD	9
Overall Study	COMPLETED	Galnobax 20% BID	10
Overall Study	COMPLETED	Galnobax 14% BID	10
Overall Study	NOT COMPLETED	Placebo	0
Overall Study	NOT COMPLETED	Galnobax 20% QD	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events72

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	Wound infection	Infections and infestations	Placebo	0	10	0
other	Wound infection	Infections and infestations	Galnobax 20% QD	0	9	0
other	Wound infection	Infections and infestations	Galnobax 20% BID	2	14	2
other	Wound infection	Infections and infestations	Galnobax 14% BID	0	11	0
other	Pyrexia	General disorders	Placebo	0	10	0
other	Pyrexia	General disorders	Galnobax 20% QD	1	9	1
other	Pyrexia	General disorders	Galnobax 20% BID	0	14	0
other	Pyrexia	General disorders	Galnobax 14% BID	1	11	1
other	Inflammation	General disorders	Placebo	0	10	0
other	Inflammation	General disorders	Galnobax 20% QD	0	9	0

1 to 10 of 72Source ClinicalTrials.gov

See all 72 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	10
Total, all-cause mortality	Galnobax 20% QD	0	9
Total, all-cause mortality	Galnobax 20% BID	0	14
Total, all-cause mortality	Galnobax 14% BID	0	11
Total, other adverse events	Placebo	1	10
Total, other adverse events	Galnobax 20% QD	3	9
Total, other adverse events	Galnobax 20% BID	6	14
Total, other adverse events	Galnobax 14% BID	6	11
Total, serious adverse events	Placebo	0	10
Total, serious adverse events	Galnobax 20% QD	0	9

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
36245145	BACKGROUND

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/NCT01113515

GET https://conductscience.org/api/trials/v1/NCT01113515/events?page=2

API reference For AI assistants