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The TRAfermin in Neuropathic Diabetic Foot Ulcer Study - Northern Europe The TRANS-North Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Olympus Biotech Corporation
ClinicalTrials.gov Identifier:
NCT01217476
First received: October 7, 2010
Last updated: August 4, 2014
Last verified: August 2014
Results First Received: July 2, 2014  
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: Diabetic Foot Ulcer of Neuropathic Origin
Intervention: Drug: Trafermin 0.01% spray

  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
Trafermin Trafermin 0.01% spray: For ulcers with a maximum diameter (longest axis) of less or equal to 6 cm, the daily dose of trafermin 0.01% spray is 5 puffs (30 microgram) sprayed onto the wound surface. If the maximum diameter (longest axis) of the ulcer is >6 cm, the ulcer should be sprayed in two parts, i.e. 5 puffs (30 microgram) sprayed onto each half of the wound surface
Placebo Matching placebo spray: For ulcers with a maximum diameter (longest axis) of less or equal to 6 cm, the daily dose of trafermin 0.01% spray is 5 puffs (30 microgram) sprayed onto the wound surface. If the maximum diameter (longest axis) of the ulcer is >6 cm, the ulcer should be sprayed in two parts, i.e. 5 puffs (30 microgram) sprayed onto each half of the wound surface

Participant Flow:   Overall Study
    Trafermin     Placebo  
STARTED     105     102  
COMPLETED     93     95  
NOT COMPLETED     12     7  
Adverse Event                 6                 1  
Physician Decision                 0                 1  
Withdrawal by Subject                 3                 3  
Surgery on the Target Limb                 0                 2  
Protocol Deviation                 1                 0  
unknown                 2                 0  



  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.
The intent-to-treat (ITT) population was defined as all randomized patients who have at least one medical evaluation during the study. Demographic and baseline characteristics were presented in terms of descriptive statistics in ITT population.

Reporting Groups
  Description
Trafermin Trafermin 0.01% spray
Placebo Matching placebo spray
Total Total of all reporting groups

Baseline Measures
    Trafermin     Placebo     Total  
Number of Participants  
[units: participants]
  105     102     207  
Age  
[units: years]
Mean ± Standard Deviation
  60.1  ± 9.0     59.4  ± 10.4     59.8  ± 9.7  
Gender  
[units: participants]
     
Female     24     14     38  
Male     81     88     169  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     0     0     0  
White     104     102     206  
More than one race     0     0     0  
Unknown or Not Reported     1     0     1  
Wound size ≤5cm^2  
[units: participants]
  81     80     161  
Wound size >5cm^2  
[units: participants]
  24     22     46  
Peripheral blood perfusion Impaired  
[units: participants]
  17     16     33  
Peripheral blood perfusion Normal  
[units: participants]
  88     86     174  
BMI  
[units: kg/m2]
Mean ± Standard Deviation
  30.19  ± 5.15     30.31  ± 4.92     30.25  ± 5.02  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Wound Closure Rate of Diabetic Foot Ulcers (DFUs) of Neuropathic Origin After a Maximum of 12 Weeks Topical Daily Application of Trafermin 0.01% Spray Compared With Placebo, in Addition to Best Local Cares   [ Time Frame: 12 weeks ]

2.  Secondary:   Relative Wound Area Regression of 40% or More at 6 Week   [ Time Frame: 6 weeks ]


  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: Mr. Akira Kondo, Manager, Clinical R&D
Organization: Olympus France S.A.S
phone: +33-1-4560-6849
e-mail: akira.kondo@olympus.fr


No publications provided


Responsible Party: Olympus Biotech Corporation
ClinicalTrials.gov Identifier: NCT01217476     History of Changes
Other Study ID Numbers: TFM-CL3-002, 2010-021015-16
Study First Received: October 7, 2010
Results First Received: July 2, 2014
Last Updated: August 4, 2014
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
Denmark: Danish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Sweden: Swedish Medical Products Agency
Hungary: National Institute of Pharmacy
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Bulgaria: Bulgarian Drug Agency
Croatia : ministry of Health and social Welfare
Slovakia: State Institute for Drug Control