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Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers (DEVO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire Regenerative Medicine, Inc.
ClinicalTrials.gov Identifier:
NCT00909870
First received: May 28, 2009
Last updated: August 9, 2013
Last verified: August 2013
Results First Received: December 31, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Venous Leg Ulcer
Interventions: Device: Dermagraft(R)
Device: Profore

  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

Screening commenced in May 2009 and ended in November 2010.

Study sites included vascular surgery, dermatology, and podiatry clinics.

A total of 913 potential subjects were screened across 58 study centers; 395 subjects were screen failures.

A total of 537 subjects were enrolled across 49 study centers.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Prior to study enrollment, all subjects signing informed consent proceeded through a two-week run-in phase in which all subjects received standard-of-care study ulcer treatment. During this phase, any subject not meeting inclusion/exclusion criteria was considered a screen failure and removed from the study.

Reporting Groups
  Description
Investigational Treatment (Dermagraft Plus Standard-of-Care) Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.
Active Control (Standard-of-Care) Weekly application of compression dressings only, in combination with systematic surgical wound debridement.

Participant Flow:   Overall Study
    Investigational Treatment (Dermagraft Plus Standard-of-Care)     Active Control (Standard-of-Care)  
STARTED     274     263  
COMPLETED     251     236  
NOT COMPLETED     23     27  
Adverse Event                 13                 7  
Protocol Violation                 1                 2  
Withdrawal by Subject                 5                 8  
Lost to Follow-up                 3                 3  
Physician Decision                 0                 2  
Other                 1                 5  



  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
Investigational Treatment (Dermagraft Plus Standard-of-Care) Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.
Control (Standard-of-Care) Weekly application of compression dressings only, in combination with systematic surgical wound debridement.
Total Total of all reporting groups

Baseline Measures
    Investigational Treatment (Dermagraft Plus Standard-of-Care)     Control (Standard-of-Care)     Total  
Number of Participants  
[units: participants]
  274     263     537  
Age  
[units: Years]
Mean ± Standard Deviation
  63.1  ± 13.04     63.2  ± 14.46     63.1  ± 13.74  
Gender  
[units: participants]
     
Female     158     146     304  
Male     116     117     233  
Region of Enrollment  
[units: participants]
     
United States     94     93     187  
Estonia     10     9     19  
Poland     81     74     155  
South Africa     73     71     144  
Germany     8     8     16  
United Kingdom     6     7     13  
Sweden     2     1     3  
Ulcer Size  
[units: centimeters-squared]
Median ( Full Range )
  5.75  
  ( 1.5 to 19.3 )  
  5.90  
  ( 2.0 to 24.8 )  
  5.9  
  ( 1.5 to 24.8 )  
Ulcer Duration  
[units: days]
Median ( Full Range )
  206  
  ( 1 to 18157 )  
  228  
  ( 23 to 3834 )  
  214  
  ( 1 to 18157 )  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Complete Healing of the Study Ulcer by Week 16.   [ Time Frame: 16 weeks ]

2.  Secondary:   Time-to-Complete Healing   [ Time Frame: From Week 0 visit to date subject's completely healed ulcer is 1st recorded as healed. If subject’s ulcer not healed at 16 weeks, the “time until CH” was censored at 112 days. ]

3.  Other Pre-specified:   Complete Healing by Week 16: Ulcers <= 12 Months Duration   [ Time Frame: 16 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
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: Mollie Carter, MD, Medical Director
Organization: Shire Regenerative Medicine
phone: (858) 754-5678
e-mail: mcarter@shire.com


No publications provided


Responsible Party: Shire Regenerative Medicine, Inc.
ClinicalTrials.gov Identifier: NCT00909870     History of Changes
Other Study ID Numbers: ABH-Dermagraft-001-08
Study First Received: May 28, 2009
Results First Received: December 31, 2012
Last Updated: August 9, 2013
Health Authority: United States: Food and Drug Administration