Trial Outcomes & Findings for Nu-3 Topical Gel for Treatment of Diabetic Foot Ulcer (NCT NCT05276401)
NCT ID: NCT05276401
Last Updated: 2024-01-30
Results Overview
Treatment emergent events related to clinical investigational product
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
28 days
Results posted on
2024-01-30
Participant Flow
Participant milestones
| Measure |
Period 1: Active
Dosage Form: Topical Antimicrobial Gel; Dosage: 5%; Frequency: BID for 28 days
Period 1: 5% Bisphosphocin Topical Gel: Topical Gel
|
Period 1: Placebo
Dosage Form: Topical Gel; Dosage: Placebo; Frequency: BID for 28 days
Period 1: Placebo Topical Gel: Topical Gel
|
Period 2: Active
Dosage Form: Topical Antimicrobial Gel; Dosage: 10%; Frequency: BID for 28 days
Period 2: 10% Bisphosphocin Topical Gel: Topical Gel
|
Period 2: Placebo
Dosage Form: Topical Gel; Dosage: Placebo; Frequency: BID for 28 days
Period 2: Placebo Topical Gel: Topical Gel
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
0
|
0
|
|
Overall Study
COMPLETED
|
2
|
1
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nu-3 Topical Gel for Treatment of Diabetic Foot Ulcer
Baseline characteristics by cohort
| Measure |
Active
n=2 Participants
Dosage Form: Topical Antimicrobial Gel; Dosage: 5% Gel, 10% Gel; Frequency: BID for 28 days
5% Bisphosphocin Topical Gel: Topical Gel
|
Placebo
n=1 Participants
Dosage Form: Topical Gel; Dosage: Placebo; Frequency: BID for 28 days
Placebo Topical Gel: Topical Gel
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 daysTreatment emergent events related to clinical investigational product
Outcome measures
| Measure |
Active
n=2 Participants
Dosage Form: Topical Antimicrobial Gel; Dosage: 5% Gel, 10% Gel; Frequency: BID for 28 days
5% Bisphosphocin Topical Gel: Topical Gel
|
Placebo
n=1 Participants
Dosage Form: Topical Gel; Dosage: Placebo; Frequency: BID for 28 days
Placebo Topical Gel: Topical Gel
|
|---|---|---|
|
To Assess the Number of Participants With Treatment-related Adverse Events After Nu-3 Gel Use on cDFU as Assessed by CTCAE v4.0
|
2 Participants
|
1 Participants
|
Adverse Events
Active
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active
n=2 participants at risk
Dosage Form: Topical Antimicrobial Gel; Dosage: 5% Gel, 10% Gel; Frequency: BID for 28 days
5% Bisphosphocin Topical Gel: Topical Gel
|
Placebo
n=1 participants at risk
Dosage Form: Topical Gel; Dosage: Placebo; Frequency: BID for 28 days
Placebo Topical Gel: Topical Gel
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
50.0%
1/2 • Number of events 1 • 28 days
|
0.00%
0/1 • 28 days
|
|
Infections and infestations
Diabetic foot infection
|
0.00%
0/2 • 28 days
|
100.0%
1/1 • Number of events 1 • 28 days
|
|
Musculoskeletal and connective tissue disorders
Metatarsalgia
|
50.0%
1/2 • Number of events 1 • 28 days
|
0.00%
0/1 • 28 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place