Trial Outcomes & Findings for Phase 3 Study to Evaluate the Safety and Efficacy of Galnobax® in Treating Diabetic Foot Ulcers (NCT NCT03998436)
NCT ID: NCT03998436
Last Updated: 2023-09-22
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
176 participants
Primary outcome timeframe
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
Results posted on
2023-09-22
Participant Flow
Participant milestones
| Measure |
Galnobax® 14% Gel Plus SoC
Esmolol Hydrochloride gel (Galnobax) administered twice daily along with Standard of Care
|
SoC Only
Only Standard of Care administered twice daily
|
Vehicle Plus SoC
Vehicle gel administered twice daily along with Standard of Care
|
|---|---|---|---|
|
Overall Study
STARTED
|
76
|
76
|
24
|
|
Overall Study
COMPLETED
|
68
|
72
|
23
|
|
Overall Study
NOT COMPLETED
|
8
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Galnobax® 14% Gel Plus SoC
n=76 Participants
Esmolol Hydrochloride gel (Galnobax) administered twice daily along with Standard of Care
|
SoC Only
n=76 Participants
Only Standard of Care administered twice daily
|
Vehicle Plus SoC
n=24 Participants
Vehicle gel administered twice daily along with Standard of Care
|
Total
n=176 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
56.5 years
STANDARD_DEVIATION 8.96 • n=76 Participants
|
56.1 years
STANDARD_DEVIATION 9.36 • n=76 Participants
|
57.3 years
STANDARD_DEVIATION 8.01 • n=24 Participants
|
56.4 years
STANDARD_DEVIATION 8.97 • n=176 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=76 Participants
|
24 Participants
n=76 Participants
|
9 Participants
n=24 Participants
|
54 Participants
n=176 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=76 Participants
|
52 Participants
n=76 Participants
|
15 Participants
n=24 Participants
|
122 Participants
n=176 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
India
|
76 participants
n=76 Participants
|
76 participants
n=76 Participants
|
24 participants
n=24 Participants
|
176 participants
n=176 Participants
|
|
Body Mass Index
|
26.7 Kg/m2
STANDARD_DEVIATION 4.05 • n=76 Participants
|
25.9 Kg/m2
STANDARD_DEVIATION 4.30 • n=76 Participants
|
25.9 Kg/m2
STANDARD_DEVIATION 3.39 • n=24 Participants
|
26.2 Kg/m2
STANDARD_DEVIATION 4.08 • n=176 Participants
|
PRIMARY outcome
Timeframe: 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 reportedPopulation: Subjects in FAS population
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.
Outcome measures
| Measure |
Galnobax® 14% Gel Plus SoC
n=68 Participants
Esmolol Hydrochloride gel (Galnobax) administered twice daily along with Standard of Care
|
SoC Only
n=72 Participants
Only Standard of Care administered twice daily
|
Vehicle Plus SoC
n=23 Participants
Vehicle gel administered twice daily along with Standard of Care
|
|---|---|---|---|
|
Proportion of Subjects Achieving Target Ulcer Closure Within 12-week Treatment Phase, as Assessed by Blinded Investigator
|
41 Participants
|
30 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 24-weeks. The ulcers achieving complete closure till end of studyProportion 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.
Outcome measures
| Measure |
Galnobax® 14% Gel Plus SoC
n=57 Participants
Esmolol Hydrochloride gel (Galnobax) administered twice daily along with Standard of Care
|
SoC Only
n=63 Participants
Only Standard of Care administered twice daily
|
Vehicle Plus SoC
n=23 Participants
Vehicle gel administered twice daily along with Standard of Care
|
|---|---|---|---|
|
Proportion of Subjects Achieving Target Ulcer Closure Till End of Study, as Assessed by the Blinded Investigator.
|
44 Participants
|
35 Participants
|
9 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24-weeksPopulation: ITT (Safety population)
Proportion of Treatment emergent adverse events (TEAEs) in all the groups
Outcome measures
| Measure |
Galnobax® 14% Gel Plus SoC
n=76 Participants
Esmolol Hydrochloride gel (Galnobax) administered twice daily along with Standard of Care
|
SoC Only
n=76 Participants
Only Standard of Care administered twice daily
|
Vehicle Plus SoC
n=24 Participants
Vehicle gel administered twice daily along with Standard of Care
|
|---|---|---|---|
|
Proportion of Subjects With Treatment Emergent Adverse Events (TEAEs)
|
10 Participants
|
14 Participants
|
9 Participants
|
Adverse Events
Galnobax® 14% Gel Plus SoC
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
SoC Only
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Vehicle Plus SoC
Serious events: 4 serious events
Other events: 9 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Galnobax® 14% Gel Plus SoC
n=76 participants at risk
Galnobax 14% gel along with Standard of Care (SoC) will be administered twice daily (76 subjects)
Esmolol Hydrochloride: Galnobax-14% gel application along with Standard of Care
|
SoC Only
n=76 participants at risk
Only Standard of Care will be administered twice daily (76 subjects)
Only Standard of Care: Only Standard of Care treatment
|
Vehicle Plus SoC
n=24 participants at risk
Vehicle gel along with Standard of Care (SoC) will be administered twice daily (24 subjects)
Vehicle Gel: Vehicle gel application along with Standard of Care
|
|---|---|---|---|
|
Infections and infestations
Cellulitis
|
0.00%
0/76 • 24 weeks i.e. till end of study
AEs collected from baseline visit i.e. after first application of treatment
|
1.3%
1/76 • Number of events 1 • 24 weeks i.e. till end of study
AEs collected from baseline visit i.e. after first application of treatment
|
8.3%
2/24 • Number of events 2 • 24 weeks i.e. till end of study
AEs collected from baseline visit i.e. after first application of treatment
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/76 • 24 weeks i.e. till end of study
AEs collected from baseline visit i.e. after first application of treatment
|
0.00%
0/76 • 24 weeks i.e. till end of study
AEs collected from baseline visit i.e. after first application of treatment
|
4.2%
1/24 • Number of events 1 • 24 weeks i.e. till end of study
AEs collected from baseline visit i.e. after first application of treatment
|
|
Infections and infestations
Meningitis bacterial
|
0.00%
0/76 • 24 weeks i.e. till end of study
AEs collected from baseline visit i.e. after first application of treatment
|
0.00%
0/76 • 24 weeks i.e. till end of study
AEs collected from baseline visit i.e. after first application of treatment
|
4.2%
1/24 • Number of events 1 • 24 weeks i.e. till end of study
AEs collected from baseline visit i.e. after first application of treatment
|
|
Infections and infestations
Septic shock
|
0.00%
0/76 • 24 weeks i.e. till end of study
AEs collected from baseline visit i.e. after first application of treatment
|
0.00%
0/76 • 24 weeks i.e. till end of study
AEs collected from baseline visit i.e. after first application of treatment
|
4.2%
1/24 • Number of events 1 • 24 weeks i.e. till end of study
AEs collected from baseline visit i.e. after first application of treatment
|
|
Infections and infestations
Wound infection
|
0.00%
0/76 • 24 weeks i.e. till end of study
AEs collected from baseline visit i.e. after first application of treatment
|
0.00%
0/76 • 24 weeks i.e. till end of study
AEs collected from baseline visit i.e. after first application of treatment
|
8.3%
2/24 • Number of events 2 • 24 weeks i.e. till end of study
AEs collected from baseline visit i.e. after first application of treatment
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
1.3%
1/76 • Number of events 1 • 24 weeks i.e. till end of study
AEs collected from baseline visit i.e. after first application of treatment
|
0.00%
0/76 • 24 weeks i.e. till end of study
AEs collected from baseline visit i.e. after first application of treatment
|
0.00%
0/24 • 24 weeks i.e. till end of study
AEs collected from baseline visit i.e. after first application of treatment
|
|
Nervous system disorders
Hypoglycaemic seizure
|
0.00%
0/76 • 24 weeks i.e. till end of study
AEs collected from baseline visit i.e. after first application of treatment
|
1.3%
1/76 • Number of events 1 • 24 weeks i.e. till end of study
AEs collected from baseline visit i.e. after first application of treatment
|
0.00%
0/24 • 24 weeks i.e. till end of study
AEs collected from baseline visit i.e. after first application of treatment
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/76 • 24 weeks i.e. till end of study
AEs collected from baseline visit i.e. after first application of treatment
|
0.00%
0/76 • 24 weeks i.e. till end of study
AEs collected from baseline visit i.e. after first application of treatment
|
4.2%
1/24 • Number of events 1 • 24 weeks i.e. till end of study
AEs collected from baseline visit i.e. after first application of treatment
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/76 • 24 weeks i.e. till end of study
AEs collected from baseline visit i.e. after first application of treatment
|
0.00%
0/76 • 24 weeks i.e. till end of study
AEs collected from baseline visit i.e. after first application of treatment
|
4.2%
1/24 • Number of events 1 • 24 weeks i.e. till end of study
AEs collected from baseline visit i.e. after first application of treatment
|
Other adverse events
| Measure |
Galnobax® 14% Gel Plus SoC
n=76 participants at risk
Galnobax 14% gel along with Standard of Care (SoC) will be administered twice daily (76 subjects)
Esmolol Hydrochloride: Galnobax-14% gel application along with Standard of Care
|
SoC Only
n=76 participants at risk
Only Standard of Care will be administered twice daily (76 subjects)
Only Standard of Care: Only Standard of Care treatment
|
Vehicle Plus SoC
n=24 participants at risk
Vehicle gel along with Standard of Care (SoC) will be administered twice daily (24 subjects)
Vehicle Gel: Vehicle gel application along with Standard of Care
|
|---|---|---|---|
|
Infections and infestations
Cellulitis
|
1.3%
1/76 • Number of events 1 • 24 weeks i.e. till end of study
AEs collected from baseline visit i.e. after first application of treatment
|
2.6%
2/76 • Number of events 2 • 24 weeks i.e. till end of study
AEs collected from baseline visit i.e. after first application of treatment
|
8.3%
2/24 • Number of events 2 • 24 weeks i.e. till end of study
AEs collected from baseline visit i.e. after first application of treatment
|
|
Infections and infestations
Wound infection
|
1.3%
1/76 • Number of events 1 • 24 weeks i.e. till end of study
AEs collected from baseline visit i.e. after first application of treatment
|
0.00%
0/76 • 24 weeks i.e. till end of study
AEs collected from baseline visit i.e. after first application of treatment
|
4.2%
1/24 • Number of events 1 • 24 weeks i.e. till end of study
AEs collected from baseline visit i.e. after first application of treatment
|
|
Vascular disorders
Hypertension
|
6.6%
5/76 • Number of events 5 • 24 weeks i.e. till end of study
AEs collected from baseline visit i.e. after first application of treatment
|
1.3%
1/76 • Number of events 1 • 24 weeks i.e. till end of study
AEs collected from baseline visit i.e. after first application of treatment
|
0.00%
0/24 • 24 weeks i.e. till end of study
AEs collected from baseline visit i.e. after first application of treatment
|
|
Renal and urinary disorders
Acute kidney injury
|
1.3%
1/76 • Number of events 1 • 24 weeks i.e. till end of study
AEs collected from baseline visit i.e. after first application of treatment
|
0.00%
0/76 • 24 weeks i.e. till end of study
AEs collected from baseline visit i.e. after first application of treatment
|
4.2%
1/24 • Number of events 1 • 24 weeks i.e. till end of study
AEs collected from baseline visit i.e. after first application of treatment
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/76 • 24 weeks i.e. till end of study
AEs collected from baseline visit i.e. after first application of treatment
|
0.00%
0/76 • 24 weeks i.e. till end of study
AEs collected from baseline visit i.e. after first application of treatment
|
4.2%
1/24 • Number of events 1 • 24 weeks i.e. till end of study
AEs collected from baseline visit i.e. after first application of treatment
|
|
Injury, poisoning and procedural complications
Wound complication
|
1.3%
1/76 • Number of events 1 • 24 weeks i.e. till end of study
AEs collected from baseline visit i.e. after first application of treatment
|
1.3%
1/76 • Number of events 1 • 24 weeks i.e. till end of study
AEs collected from baseline visit i.e. after first application of treatment
|
8.3%
2/24 • Number of events 2 • 24 weeks i.e. till end of study
AEs collected from baseline visit i.e. after first application of treatment
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/76 • 24 weeks i.e. till end of study
AEs collected from baseline visit i.e. after first application of treatment
|
2.6%
2/76 • Number of events 2 • 24 weeks i.e. till end of study
AEs collected from baseline visit i.e. after first application of treatment
|
4.2%
1/24 • Number of events 1 • 24 weeks i.e. till end of study
AEs collected from baseline visit i.e. after first application of treatment
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/76 • 24 weeks i.e. till end of study
AEs collected from baseline visit i.e. after first application of treatment
|
1.3%
1/76 • Number of events 1 • 24 weeks i.e. till end of study
AEs collected from baseline visit i.e. after first application of treatment
|
4.2%
1/24 • Number of events 1 • 24 weeks i.e. till end of study
AEs collected from baseline visit i.e. after first application of treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee There is an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. The sponsor has prepared an integrated clinical/statistical report. As this was a multicenter study, any publication/presentation of data was to include the entire study population. Publication/presentation of data from individual study centers is not allowed without explicit permission from the sponsor.
- Publication restrictions are in place
Restriction type: OTHER