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

  Hide Study Locations
Locations
United States, Alabama
Costal Clinical Research
Mobile, Alabama, United States, 36608
United States, California
Stockdale Podiatry Group
Bakersfield, California, United States, 93309
Center for Clinical Research
Castro Valley, California, United States, 94546
Diabetic Foot and Wound Treatment Center
El Centro, California, United States, 92243
Sacramento Foot and Ankle Center
Fair Oaks, California, United States, 95628
Advanced Foot Care and Clinical Research Center
Fresno, California, United States, 93722
Center for Clinical Research
Fresno, California, United States, 94115
California School of Podiatry Medicine at Samuel Merritt University
Oakland, California, United States, 94609
Northern California Foot and Ankle Center
Santa Rosa, California, United States, 95403
United States, Florida
Bay Pines VA Healthcare System
Bay Pines, Florida, United States, 33744
Advanced Pharma CR, LLC
Miami, Florida, United States, 33136
South Florida Wound Care Group
Tamarac, Florida, United States, 33321
C/O Center for Wound Care
Wellington, Florida, United States, 33414
United States, Georgia
Village Podiatry Center
Atlanta, Georgia, United States, 30308
United States, Idaho
Idaho Falls Infectious Diseases, PLLC
Idaho Falls, Idaho, United States, 83404
United States, Illinois
Springfield Clinic
Springfield, Illinois, United States, 62703
United States, Indiana
Infectious Disease of Indiana
Indianapolis, Indiana, United States, 46260
United States, Louisiana
Benchmark Research
Metarie, Louisiana, United States, 70006
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Cambridge Health Alliance
Cambridge, Massachusetts, United States, 02139
United States, Montana
Montana Medical Research
Missoula, Montana, United States, 59808
United States, Nevada
Advanced Foot and Ankle Center
Las Vegas, Nevada, United States, 89119
United States, New York
Excelsior Foundation of WNY
Amherst, New York, United States, 14226
Private Practice
East Setauket, New York, United States, 11733
Columbia University Medical Center
New York, New York, United States, 10034
United States, Pennsylvania
Penn North Center For Advanced Wound Care
Erie, Pennsylvania, United States, 16544
Temple University School of Podiatric Medicine
Philadelphia, Pennsylvania, United States, 19107
Western Pennsylvania Hospital
Pittsburg, Pennsylvania, United States, 15224
United States, Texas
Limb Salvage Center
Dallas, Texas, United States, 75231
Department of Plastic Surgery
Dallas, Texas, United States, 75390
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
United States, Utah
Foot and Ankle Institute
St. George, Utah, United States, 84770
Netherlands Antilles
St. Elisabeth's Hospital
Willemstad, Curacao, Netherlands Antilles
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