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: August 25, 2014
Last verified: August 2014

January 31, 2010
August 25, 2014
April 2010
June 2014   (final data collection date for primary outcome measure)
Incidence of complete wound closure [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01060670 on ClinicalTrials.gov Archive Site
  • Time to complete wound closure [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Incidence of recurrence [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: 28 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Safety and Efficacy Study of INTEGRA® Dermal Regeneration Template for the Treatment of Diabetic Foot Ulcers
A Multi-Center, Randomized, Controlled Clinical Trial to Evaluate The Safety and Effectiveness of Integra® Dermal Regeneration Template for the Treatment of Neuropathic Diabetic Foot Ulcers

The objective of this study is to evaluate the safety and effectiveness of the INTEGRA® Dermal Regeneration Template for the treatment of diabetic foot ulcers located distal to the malleolus in subjects with diabetes mellitus, neuropathy, and without significantly compromised arterial circulation.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Foot Ulcer, Diabetic
  • Device: Integra® Dermal Regeneration Template
    Application of Integra® Dermal Regeneration Template in diabetic foot ulcer
  • Other: Conventional Wound Therapy
    Conventional Wound Therapy
  • Experimental: Dermal Replacement Device
    Device: INTEGRA® Dermal Regeneration Template
    Intervention: Device: Integra® Dermal Regeneration Template
  • Active Comparator: Moist Wound Therapy
    Saline plus secondary dressing
    Intervention: Other: Conventional Wound Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
307
July 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type I or Type II diabetes mellitus
  • Glycosylated hemoglobin, HbA1c, ≤ 12%
  • Diabetic foot ulcer located below the ankle and/or on the bottom of the foot which has been present for 30 days and is sufficient size to qualify for the study
  • Good vascular perfusion of the affected limb

Exclusion Criteria:

  • Gangrene, infection, or osteomyelitis
  • Sensitivity to bovine collagen and/or chondroitin.
  • Ulcers resulting from other health conditions besides diabetes
  • Conditions or laboratory values which are not within the specified ranges
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Netherlands Antilles
 
NCT01060670
IDRT/DFU US - 2009-3
No
Integra LifeSciences Corporation
Integra LifeSciences Corporation
Not Provided
Not Provided
Integra LifeSciences Corporation
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP