Study of Thymosin Beta 4 in Patients With Pressure Ulcers

This study has been completed.
Sponsor:
Information provided by:
RegeneRx Biopharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00382174
First received: September 26, 2006
Last updated: January 6, 2010
Last verified: January 2010
Results First Received: December 29, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Pressure Ulcers
Interventions: Drug: Placebo
Drug: Thymosin Beta 4

  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
Recruitment started in 2005 and ended in 2008 using 13 sites: Medical Center Clinics, Wound Care Center, Veteran Administration Centers, and Clinical Research Centers.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Prior to randomization, patients needed to meet specific inclusion and exclusion criteria: results of pregnancy tests needed to be negative; glycosylated hemoglobin tests needed to be less or equal to 8.5% of the total hemoglobin.

Reporting Groups
  Description
Placebo 0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
Tβ4 at 3 Doses 0.01% Tβ4,w/w 0.02% Tβ4,w/w 0.1% Tβ4,w/w
Placebo vs. Thymosin Beta 4 at 3 Doses Placebo dose 0.00% thymosin beta 4 vs. thymosin beta 4 at 0.01%, 0.02% and 0.1%

Participant Flow:   Overall Study
    Placebo     Tβ4 at 3 Doses     Placebo vs. Thymosin Beta 4 at 3 Doses  
STARTED     18     54     72  
COMPLETED     14     37     51  
NOT COMPLETED     4     17     21  
Lost to Follow-up                 1                 4                 5  
Adverse Event                 1                 4                 5  
Withdrawal by Subject                 1                 4                 5  
Non compliance                 1                 0                 1  
Physician Decision                 0                 2                 2  
Failed to meet criteria                 0                 1                 1  
Wounds merged                 0                 2                 2  



  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
Placebo 0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
Tβ4 at 3 Doses 0.01% Tβ4,w/w 0.02% Tβ4,w/w 0.1% Tβ4,w/w
Total Total of all reporting groups

Baseline Measures
    Placebo     Tβ4 at 3 Doses     Total  
Number of Participants  
[units: participants]
  18     54     72  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     17     38     55  
>=65 years     1     16     17  
Gender  
[units: participants]
     
Female     2     14     16  
Male     16     40     56  
Region of Enrollment  
[units: participants]
     
United States     18     54     72  



  Outcome Measures
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1.  Primary:   Safety and Tolerability of Thymosin Beta 4 (Tβ4)Applied for up to 84 Days   [ Time Frame: Up to 84 days ]

2.  Secondary:   Wound Healing Effectiveness of Tβ4 Applied for up to 84 Days   [ Time Frame: Up to 84 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
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  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: Nabila Turjman, PhD, Executive Director, Regulatory Affairs
Organization: RegeneRx Biopharmaceuticals, Inc.
phone: 301-280-1992 ext 108
e-mail: nturjman@regenerx.com


No publications provided


Responsible Party: David Crockford, VP, Clinical and Regulatory Affairs, RegeneRx Biopharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00382174     History of Changes
Other Study ID Numbers: SSPU
Study First Received: September 26, 2006
Results First Received: December 29, 2009
Last Updated: January 6, 2010
Health Authority: United States: Food and Drug Administration