Trial Outcomes & Findings for Pexiganan Versus Placebo Control for the Treatment of Mild Infections of Diabetic Foot Ulcers (NCT NCT01594762)
NCT ID: NCT01594762
Last Updated: 2017-06-14
Results Overview
The numbers of participants with Clinical Response, defined as resolution of infection, are reported.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
200 participants
Primary outcome timeframe
28 days
Results posted on
2017-06-14
Participant Flow
Participant milestones
| Measure |
Topical Pexiganan Cream 0.8%
Drug: Topical pexiganan cream 0.8%
Topical pexiganan cream 0.8%: 14 days of treatment + 14 days of follow-up (28-day trial period)
Standard wound care: 28-day trial period
|
Topical Placebo Control
Drug: Topical placebo cream
Topical placebo cream: 14 days of treatment + 14 days of follow-up (28-day trial period)
Standard wound care: 28-day trial period
|
|---|---|---|
|
Overall Study
STARTED
|
97
|
103
|
|
Overall Study
COMPLETED
|
86
|
93
|
|
Overall Study
NOT COMPLETED
|
11
|
10
|
Reasons for withdrawal
| Measure |
Topical Pexiganan Cream 0.8%
Drug: Topical pexiganan cream 0.8%
Topical pexiganan cream 0.8%: 14 days of treatment + 14 days of follow-up (28-day trial period)
Standard wound care: 28-day trial period
|
Topical Placebo Control
Drug: Topical placebo cream
Topical placebo cream: 14 days of treatment + 14 days of follow-up (28-day trial period)
Standard wound care: 28-day trial period
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
10
|
10
|
Baseline Characteristics
Pexiganan Versus Placebo Control for the Treatment of Mild Infections of Diabetic Foot Ulcers
Baseline characteristics by cohort
| Measure |
Topical Pexiganan Cream 0.8%
n=97 Participants
Drug: Topical pexiganan cream 0.8%
Topical pexiganan cream 0.8%: 14 days of treatment
Standard wound care: 28-day trial period
|
Topical Placebo Control
n=103 Participants
Drug: Topical placebo cream
Topical placebo cream: 14 days of treatment
Standard wound care: 28-day trial period
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.37 years
STANDARD_DEVIATION 12.71 • n=5 Participants
|
57.14 years
STANDARD_DEVIATION 10.61 • n=7 Participants
|
57.25 years
STANDARD_DEVIATION 11.65 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
31 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
66 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
19 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
78 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
153 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
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
97 participants
n=5 Participants
|
103 participants
n=7 Participants
|
200 participants
n=5 Participants
|
|
Wound surface area
<1 sq cm
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Wound surface area
1 - <2 sq cm
|
50 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Wound surface area
>=2 sq cm
|
43 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Wound surface area
Missing
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: Intent-To-Treat
The numbers of participants with Clinical Response, defined as resolution of infection, are reported.
Outcome measures
| Measure |
Topical Pexiganan Cream 0.8%
n=97 Participants
Drug: Topical pexiganan cream 0.8%
Topical pexiganan cream 0.8%: 14 days of treatment
|
Topical Placebo Control
n=103 Participants
Drug: Topical placebo cream
Topical placebo cream: 14 days of treatment
|
|---|---|---|
|
Number of Participants With Clinical Response
|
56 Participants
|
54 Participants
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Intent-To-Treat Microbiological (positive for baseline pathogens)
The numbers of participants with Microbiological Response, defined are eradication of all baseline pathogens, are reported.
Outcome measures
| Measure |
Topical Pexiganan Cream 0.8%
n=63 Participants
Drug: Topical pexiganan cream 0.8%
Topical pexiganan cream 0.8%: 14 days of treatment
|
Topical Placebo Control
n=75 Participants
Drug: Topical placebo cream
Topical placebo cream: 14 days of treatment
|
|---|---|---|
|
Number of Participants With Microbiological Response
|
18 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Safety
The number of participants with TEAEs, including Serious TEAEs, are reported
Outcome measures
| Measure |
Topical Pexiganan Cream 0.8%
n=97 Participants
Drug: Topical pexiganan cream 0.8%
Topical pexiganan cream 0.8%: 14 days of treatment
|
Topical Placebo Control
n=103 Participants
Drug: Topical placebo cream
Topical placebo cream: 14 days of treatment
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAE)
Incidence of any TEAE
|
25 Participants
|
21 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAE)
Incidence of Serious TEAE
|
8 Participants
|
2 Participants
|
Adverse Events
Topical Pexiganan Cream 0.8%
Serious events: 8 serious events
Other events: 6 other events
Deaths: 0 deaths
Topical Placebo Control
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Topical Pexiganan Cream 0.8%
n=97 participants at risk
Drug: Topical pexiganan cream 0.8%
Topical pexiganan cream 0.8%: 14 days of treatment
|
Topical Placebo Control
n=103 participants at risk
Drug: Topical placebo cream
Topical placebo cream: 14 days of treatment
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
1.0%
1/97 • Number of events 1 • 28 days
|
0.00%
0/103 • 28 days
|
|
Infections and infestations
Cellulitis
|
2.1%
2/97 • Number of events 2 • 28 days
|
0.97%
1/103 • Number of events 1 • 28 days
|
|
Infections and infestations
Osteomyelitis
|
2.1%
2/97 • Number of events 2 • 28 days
|
0.97%
1/103 • Number of events 1 • 28 days
|
|
Metabolism and nutrition disorders
Diabetic ketoacidiosis
|
1.0%
1/97 • Number of events 1 • 28 days
|
0.00%
0/103 • 28 days
|
|
Nervous system disorders
Lethargy
|
1.0%
1/97 • Number of events 1 • 28 days
|
0.00%
0/103 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.1%
2/97 • Number of events 2 • 28 days
|
0.00%
0/103 • 28 days
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
1.0%
1/97 • Number of events 1 • 28 days
|
0.00%
0/103 • 28 days
|
|
Surgical and medical procedures
Foot surgery
|
1.0%
1/97 • Number of events 1 • 28 days
|
0.00%
0/103 • 28 days
|
Other adverse events
| Measure |
Topical Pexiganan Cream 0.8%
n=97 participants at risk
Drug: Topical pexiganan cream 0.8%
Topical pexiganan cream 0.8%: 14 days of treatment
|
Topical Placebo Control
n=103 participants at risk
Drug: Topical placebo cream
Topical placebo cream: 14 days of treatment
|
|---|---|---|
|
Infections and infestations
Osteomyelitis
|
3.1%
3/97 • Number of events 3 • 28 days
|
0.00%
0/103 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.1%
3/97 • Number of events 3 • 28 days
|
0.00%
0/103 • 28 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If no multi-site publication within 18 months of study completion, Site shall have right to publish subject to: 1) Prior to submitting/presenting, Site shall provide Sponsor a copy; Sponsor shall have 60 days to review/comment. 2) Site shall remove any Confidential Information prior to submitting/presenting the materials. 3) Site shall further delay publication/presentation for up to 120 days to allow Sponsor to protect its interests in any Sponsor Inventions described in any such materials.
- Publication restrictions are in place
Restriction type: OTHER