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Trial record 35 of 442 for:    Foot Diseases | "Diabetic Foot"

Pexiganan Versus Placebo Control for the Treatment of Mild Infections of Diabetic Foot Ulcers (OneStep-2)

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ClinicalTrials.gov Identifier: NCT01594762
Recruitment Status : Completed
First Posted : May 9, 2012
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
Dipexium Pharmaceuticals, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Diabetic Foot Infection
Interventions Drug: Topical pexiganan cream 0.8%
Drug: Topical placebo cream
Other: Standard wound care
Enrollment 200
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Topical Pexiganan Cream 0.8% Topical Placebo Control
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 97 103
Completed 86 93
Not Completed 11 10
Reason Not Completed
Withdrawal by Subject             1             0
Lost to Follow-up             10             10
Arm/Group Title Topical Pexiganan Cream 0.8% Topical Placebo Control Total
Hide Arm/Group Description

Drug: Topical pexiganan cream 0.8%

Topical pexiganan cream 0.8%: 14 days of treatment

Standard wound care: 28-day trial period

Drug: Topical placebo cream

Topical placebo cream: 14 days of treatment

Standard wound care: 28-day trial period

Total of all reporting groups
Overall Number of Baseline Participants 97 103 200
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 97 participants 103 participants 200 participants
57.37  (12.71) 57.14  (10.61) 57.25  (11.65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants 103 participants 200 participants
Female
27
  27.8%
22
  21.4%
49
  24.5%
Male
70
  72.2%
81
  78.6%
151
  75.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants 103 participants 200 participants
Hispanic or Latino
31
  32.0%
35
  34.0%
66
  33.0%
Not Hispanic or Latino
66
  68.0%
68
  66.0%
134
  67.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants 103 participants 200 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
19
  19.6%
27
  26.2%
46
  23.0%
White
78
  80.4%
75
  72.8%
153
  76.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   1.0%
1
   0.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 97 participants 103 participants 200 participants
97 103 200
Wound surface area  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants 103 participants 200 participants
<1 sq cm
4
   4.1%
5
   4.9%
9
   4.5%
1 - <2 sq cm
50
  51.5%
54
  52.4%
104
  52.0%
>=2 sq cm
43
  44.3%
43
  41.7%
86
  43.0%
Missing
0
   0.0%
1
   1.0%
1
   0.5%
1.Primary Outcome
Title Number of Participants With Clinical Response
Hide Description The numbers of participants with Clinical Response, defined as resolution of infection, are reported.
Time Frame 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-To-Treat
Arm/Group Title Topical Pexiganan Cream 0.8% Topical Placebo Control
Hide Arm/Group Description:

Drug: Topical pexiganan cream 0.8%

Topical pexiganan cream 0.8%: 14 days of treatment

Drug: Topical placebo cream

Topical placebo cream: 14 days of treatment

Overall Number of Participants Analyzed 97 103
Measure Type: Count of Participants
Unit of Measure: Participants
56
  57.7%
54
  52.4%
2.Secondary Outcome
Title Number of Participants With Microbiological Response
Hide Description The numbers of participants with Microbiological Response, defined are eradication of all baseline pathogens, are reported.
Time Frame 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-To-Treat Microbiological (positive for baseline pathogens)
Arm/Group Title Topical Pexiganan Cream 0.8% Topical Placebo Control
Hide Arm/Group Description:

Drug: Topical pexiganan cream 0.8%

Topical pexiganan cream 0.8%: 14 days of treatment

Drug: Topical placebo cream

Topical placebo cream: 14 days of treatment

Overall Number of Participants Analyzed 63 75
Measure Type: Count of Participants
Unit of Measure: Participants
18
  28.6%
27
  36.0%
3.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAE)
Hide Description The number of participants with TEAEs, including Serious TEAEs, are reported
Time Frame 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety
Arm/Group Title Topical Pexiganan Cream 0.8% Topical Placebo Control
Hide Arm/Group Description:

Drug: Topical pexiganan cream 0.8%

Topical pexiganan cream 0.8%: 14 days of treatment

Drug: Topical placebo cream

Topical placebo cream: 14 days of treatment

Overall Number of Participants Analyzed 97 103
Measure Type: Count of Participants
Unit of Measure: Participants
Incidence of any TEAE
25
  25.8%
21
  20.4%
Incidence of Serious TEAE
8
   8.2%
2
   1.9%
Time Frame 28 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Topical Pexiganan Cream 0.8% Topical Placebo Control
Hide Arm/Group Description

Drug: Topical pexiganan cream 0.8%

Topical pexiganan cream 0.8%: 14 days of treatment

Drug: Topical placebo cream

Topical placebo cream: 14 days of treatment

All-Cause Mortality
Topical Pexiganan Cream 0.8% Topical Placebo Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/97 (0.00%)      0/103 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Topical Pexiganan Cream 0.8% Topical Placebo Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/97 (8.25%)      2/103 (1.94%)    
Cardiac disorders     
Acute myocardial infarction * 1  1/97 (1.03%)  1 0/103 (0.00%)  0
Infections and infestations     
Cellulitis * 1  2/97 (2.06%)  2 1/103 (0.97%)  1
Osteomyelitis * 1  2/97 (2.06%)  2 1/103 (0.97%)  1
Metabolism and nutrition disorders     
Diabetic ketoacidiosis * 1  1/97 (1.03%)  1 0/103 (0.00%)  0
Nervous system disorders     
Lethargy * 1  1/97 (1.03%)  1 0/103 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Dyspnoea * 1  2/97 (2.06%)  2 0/103 (0.00%)  0
Skin and subcutaneous tissue disorders     
Skin necrosis * 1  1/97 (1.03%)  1 0/103 (0.00%)  0
Surgical and medical procedures     
Foot surgery * 1  1/97 (1.03%)  1 0/103 (0.00%)  0
1
Term from vocabulary, MedDRA (17.0)
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Topical Pexiganan Cream 0.8% Topical Placebo Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/97 (6.19%)      0/103 (0.00%)    
Infections and infestations     
Osteomyelitis * 1  3/97 (3.09%)  3 0/103 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Dyspnoea * 1  3/97 (3.09%)  3 0/103 (0.00%)  0
1
Term from vocabulary, MedDRA (17.0)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Robert J DeLuccia
Organization: Dipexium Pharmaceuticals, Inc
Phone: +19145226503
Responsible Party: Dipexium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01594762     History of Changes
Other Study ID Numbers: DPX-306
First Submitted: May 7, 2012
First Posted: May 9, 2012
Results First Submitted: April 14, 2017
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017