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
  Purpose

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.


Condition Intervention
Foot Ulcer, Diabetic
Device: Integra® Dermal Regeneration Template
Other: Conventional Wound Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Integra LifeSciences Corporation:

Primary Outcome Measures:
  • Incidence of complete wound closure [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 307
Study Start Date: April 2010
Study Completion Date: July 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dermal Replacement Device
Device: INTEGRA® Dermal Regeneration Template
Device: Integra® Dermal Regeneration Template
Application of Integra® Dermal Regeneration Template in diabetic foot ulcer
Active Comparator: Moist Wound Therapy
Saline plus secondary dressing
Other: Conventional Wound Therapy
Conventional Wound Therapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01060670

  Show 33 Study Locations
Sponsors and Collaborators
Integra LifeSciences Corporation
  More Information

No publications provided

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
Last Updated: August 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Integra LifeSciences Corporation:
Foot Ulcer
Diabetic
Wound Healing
Integra Dermal Regeneration Template

Additional relevant MeSH terms:
Ulcer
Diabetic Foot
Foot Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases

ClinicalTrials.gov processed this record on September 18, 2014