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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dipexium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01594762
First received: May 7, 2012
Last updated: May 19, 2017
Last verified: April 2017
Results First Received: April 14, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    Topical Pexiganan Cream 0.8%   Topical Placebo Control
STARTED   97   103 
COMPLETED   86   93 
NOT COMPLETED   11   10 
Withdrawal by Subject                1                0 
Lost to Follow-up                10                10 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Topical Pexiganan Cream 0.8%

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

Drug: Topical placebo cream

Topical placebo cream: 14 days of treatment

Standard wound care: 28-day trial period

Total Total of all reporting groups

Baseline Measures
   Topical Pexiganan Cream 0.8%   Topical Placebo Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 97   103   200 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.37  (12.71)   57.14  (10.61)   57.25  (11.65) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      27  27.8%      22  21.4%      49  24.5% 
Male      70  72.2%      81  78.6%      151  75.5% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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 
[Units: Participants]
     
United States   97   103   200 
Wound surface area 
[Units: Participants]
Count of 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% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Clinical Response   [ Time Frame: 28 days ]

2.  Secondary:   Number of Participants With Microbiological Response   [ Time Frame: 28 days ]

3.  Secondary:   Number of Participants With Treatment-Emergent Adverse Events (TEAE)   [ Time Frame: 28 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Robert J DeLuccia
Organization: Dipexium Pharmaceuticals, Inc
phone: +19145226503
e-mail: delucciarj@gmail.com



Responsible Party: Dipexium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01594762     History of Changes
Other Study ID Numbers: DPX-306
Study First Received: May 7, 2012
Results First Received: April 14, 2017
Last Updated: May 19, 2017