Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pexiganan Versus Placebo Control for the Treatment of Mild Infections of Diabetic Foot Ulcers (OneStep-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01590758
Recruitment Status : Completed
First Posted : May 3, 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 189
Recruitment Details Subjects recruited at outpatient clinics and practices
Pre-assignment Details No wash-out or run-in periods; eligible subjects were immediately assigned to treatment
Arm/Group Title Topical Pexiganan Cream 0.8% Topical Placebo Control
Hide Arm/Group Description

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 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 85 104
Completed 80 97
Not Completed 5 7
Reason Not Completed
Withdrawal by Subject             0             3
Physician Decision             1             2
Lost to Follow-up             4             2
Arm/Group Title Topical Pexiganan Cream 0.8% Topical Placebo Control Total
Hide Arm/Group Description

Topical pexiganan cream 0.8%: 14 days of treatment

Standard wound care: 28-day trial period

Topical placebo cream: 14 days of treatment

Standard wound care: 28-day trial period

Total of all reporting groups
Overall Number of Baseline Participants 85 104 189
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Age Number Analyzed 85 participants 104 participants 189 participants
59.22  (10.14) 58.42  (10.97) 58.78  (10.58)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 85 participants 104 participants 189 participants
Female
22
  25.9%
31
  29.8%
53
  28.0%
Male
63
  74.1%
73
  70.2%
136
  72.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 85 participants 104 participants 189 participants
Hispanic or Latino
39
  45.9%
52
  50.0%
91
  48.1%
Not Hispanic or Latino
46
  54.1%
52
  50.0%
98
  51.9%
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 85 participants 104 participants 189 participants
American Indian or Alaska Native
1
   1.2%
0
   0.0%
1
   0.5%
Asian
1
   1.2%
1
   1.0%
2
   1.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   1.0%
1
   0.5%
Black or African American
19
  22.4%
17
  16.3%
36
  19.0%
White
64
  75.3%
82
  78.8%
146
  77.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
3
   2.9%
3
   1.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 85 participants 104 participants 189 participants
85 104 189
Wound surface area  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 85 participants 104 participants 189 participants
<1 sq cm
1
   1.2%
1
   1.0%
2
   1.1%
1 - <2 sq cm
41
  48.2%
52
  50.0%
93
  49.2%
>=2 sq cm
43
  50.6%
51
  49.0%
94
  49.7%
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
Hide 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:
Topical pexiganan cream 0.8%: 14 days of treatment
Topical placebo cream: 14 days of treatment
Overall Number of Participants Analyzed 85 104
Measure Type: Count of Participants
Unit of Measure: Participants
43
  50.6%
63
  60.6%
2.Secondary Outcome
Title Number of Participants With Microbiological Success
Hide Description The numbers of participants with Microbiological Response, defined as eradication of all initial pathogens, are reported.
Time Frame 28 days
Hide 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:
Topical pexiganan cream 0.8%: 14 days of treatment
Topical placebo cream: 14 days of treatment
Overall Number of Participants Analyzed 59 76
Measure Type: Count of Participants
Unit of Measure: Participants
16
  27.1%
28
  36.8%
3.Secondary Outcome
Title Number of Participants With Treatment-emergent Adverse Events (TEAE)
Hide Description The numbers of participants with TEAEs, including those with Serious TEAEs, are reported
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety
Arm/Group Title Topical Pexiganan Cream 0.8% Topical Placebo Control
Hide Arm/Group Description:
Topical pexiganan cream 0.8%: 14 days of treatment
Topical placebo cream: 14 days of treatment
Overall Number of Participants Analyzed 85 104
Measure Type: Count of Participants
Unit of Measure: Participants
Incidence of any TEAE
26
  30.6%
25
  24.0%
Incidence of Serious TEAE
9
  10.6%
3
   2.9%
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 Topical pexiganan cream 0.8%: 14 days of treatment 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   0/85 (0.00%)      0/104 (0.00%)    
Hide Serious Adverse Events
Topical Pexiganan Cream 0.8% Topical Placebo Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/85 (10.59%)      3/104 (2.88%)    
Infections and infestations     
Osteomyelitis * 1  3/85 (3.53%)  3 0/104 (0.00%)  0
Gangrene * 1  2/85 (2.35%)  2 0/104 (0.00%)  0
Infection * 1  2/85 (2.35%)  2 0/104 (0.00%)  0
Pneumonia * 1  1/85 (1.18%)  1 0/104 (0.00%)  0
Urosepsis * 1  1/85 (1.18%)  1 0/104 (0.00%)  0
Metabolism and nutrition disorders     
Diabetes inadequate control * 1  0/85 (0.00%)  0 1/104 (0.96%)  1
Fluid overload * 1  0/85 (0.00%)  0 1/104 (0.96%)  1
Musculoskeletal and connective tissue disorders     
Musculoskeletal chest pain * 1  1/85 (1.18%)  1 0/104 (0.00%)  0
Renal and urinary disorders     
Renal failure * 1  1/85 (1.18%)  1 1/104 (0.96%)  1
1
Term from vocabulary, MedDRA (17.0)
*
Indicates events were collected by non-systematic assessment
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   6/85 (7.06%)      4/104 (3.85%)    
Infections and infestations     
Cellulitis * 1  3/85 (3.53%)  3 1/104 (0.96%)  1
Osteomyelitis * 1  3/85 (3.53%)  3 2/104 (1.92%)  2
Skin and subcutaneous tissue disorders     
Skin ulcer * 1  1/85 (1.18%)  1 4/104 (3.85%)  4
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
Layout table for Results Point of Contact information
Name/Title: Robert J DeLuccia
Organization: Dipexium Pharmaceuticals, Inc
Phone: +19145226503
EMail: delucciarj@gmail.com
Layout table for additonal information
Responsible Party: Dipexium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01590758    
Other Study ID Numbers: DPX-305
First Submitted: April 27, 2012
First Posted: May 3, 2012
Results First Submitted: April 14, 2017
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017