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A Safety and Efficacy Study of INTEGRA® Dermal Regeneration Template for the Treatment of Diabetic Foot Ulcers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Integra LifeSciences Corporation
ClinicalTrials.gov Identifier:
NCT01060670
First received: January 31, 2010
Last updated: July 29, 2016
Last verified: July 2016
Results First Received: March 23, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Neuropathic Diabetic Ulcer - Foot
Interventions: Device: Integra® Dermal Regeneration Template
Other: Conventional Wound Therapy

  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
Participants were recruited based on physician referral at 36 medical centers between March 2010 and November 2013. The first study participant was enrolled in April 2010 and the last study participant was enrolled in November 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants participated in a Run-In phase that must last a minimum of 14 days, but may have been extended up to 17 days to allow for scheduling of the randomization visit.

Reporting Groups
  Description
Active Treatment INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing, gauze wrap and an offloading/protective device were used in conjunction with the IDRT.
Control Treatment Control Treatment was applied to sharply debrided study ulcer wound bed within an aseptic field. Moist wound therapy consisted of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing, gauze wrap and an offloading/protective device.

Participant Flow for 3 periods

Period 1:   Run In
    Active Treatment   Control Treatment
STARTED   0   545 
COMPLETED   0   307 
NOT COMPLETED   0   238 
screen failure                0                238 

Period 2:   Treatment Phase
    Active Treatment   Control Treatment
STARTED   154   153 
Healed at End of Treatment Phase   79   49 
Did Not Heal by Treatment Visit 17   49   68 
Withdrew From Treatment   26   36 
COMPLETED   128   117 
NOT COMPLETED   26   36 

Period 3:   Follow up Phase
    Active Treatment   Control Treatment
STARTED   128   117 
Recurrence   14   9 
Withdrew From Follow up Phase   22   35 
COMPLETED   106   82 
NOT COMPLETED   22   35 



  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
Active Treatment INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing and a gauze wrap and, an offloading/protective device were to be used in conjunction with the IDRT.
Control Treatment Control Treatment consisted of moist wound therapy and was comprised of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing and a gauze wrap and, an offloading/protective device
Total Total of all reporting groups

Baseline Measures
   Active Treatment   Control Treatment   Total 
Overall Participants Analyzed 
[Units: Participants]
 154   153   307 
Age 
[Units: Years]
Mean (Full Range)
 55.8 
 (31 to 82) 
 57.3 
 (28 to 82) 
 56.5 
 (28 to 82) 
Gender 
[Units: Participants]
     
Female   36   39   75 
Male   118   114   232 
Region of Enrollment 
[Units: Participants]
     
United States   152   151   303 
Netherlands Antilles   2   2   4 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Incidence of Complete Wound Closure   [ Time Frame: 16 weeks ]

2.  Secondary:   Incidence of Complete Wound Closure   [ Time Frame: 16 weeks ]

3.  Secondary:   Time to Complete Wound Closure   [ Time Frame: 16 weeks ]

4.  Secondary:   Time to Complete Wound Closure   [ Time Frame: 16 weeks ]

5.  Secondary:   Rate of Wound Closure   [ Time Frame: 16 weeks ]

6.  Secondary:   Incidence of Ulcer Recurrence   [ Time Frame: 12 weeks ]

7.  Secondary:   Change in Short Form Health Survey (SF-36) Quality of Life Metrics   [ Time Frame: Baseline and 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
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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: Katie Bush, PhD- Manager, Global Medical Affairs- Tissue Technology
Organization: Integra LifeSciences, Inc.
phone: 617-268-1616 ext 267
e-mail: katie.bush@integralife.com



Responsible Party: Integra LifeSciences Corporation
ClinicalTrials.gov Identifier: NCT01060670     History of Changes
Other Study ID Numbers: IDRT/DFU US - 2009-3
Study First Received: January 31, 2010
Results First Received: March 23, 2016
Last Updated: July 29, 2016
Health Authority: United States: Food and Drug Administration