A Safety and Efficacy Study of INTEGRA® Dermal Regeneration Template for the Treatment of Diabetic Foot Ulcers
NCT ID: NCT01060670
Last Updated: 2016-09-22
Study Results
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View full resultsBasic Information
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COMPLETED
NA
545 participants
INTERVENTIONAL
2010-04-30
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dermal Replacement Device
Device: INTEGRA® Dermal Regeneration Template
Integra® Dermal Regeneration Template
Application of Integra® Dermal Regeneration Template in diabetic foot ulcer
Moist Wound Therapy
0.9% Saline gel
Conventional Wound Therapy
Conventional Wound Therapy
Interventions
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Integra® Dermal Regeneration Template
Application of Integra® Dermal Regeneration Template in diabetic foot ulcer
Conventional Wound Therapy
Conventional Wound Therapy
Eligibility Criteria
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Inclusion Criteria
* Glycosylated hemoglobin, HbA1c, ≤ 12%
* Negative serum pregnancy test at screening for female participants of child-bearing potential
* Willing and able to maintain the required off-loading (as applicable for the location for the ulcer) and applicable dressing changes
* At least one DFU that met the following criteria:
1. Ulcer was diagnosed as a full-thickness neuropathic DFU that was located distal to the malleolus (excluding ulcers between the toes but including those of the heel),
2. Minimum 2-cm margin between the qualifying study ulcer and any other ulcers on the specified foot (post debridement),
3. Area greater than or equal to 1 square centimeter and less than or equal to 12 square centimeters (post debridement at the time of randomization),
4. Wagner grade 1 or 2,
5. Depth less than or equal to 5 millimeters with no exposed capsule, tendon or bone and no tunneling, undermining or sinus tracts,
6. Duration of the study ulcer was at least 30 days at the time of the screening visit
* Adequate vascular perfusion of the affected limb
Exclusion Criteria
* History of hypersensitivity to bovine collagen and/or chondroitin.
* Pregnancy
* Previous treatment under this clinical protocol
* Participation in another clinical trial involving a device or systematically administered investigational study drug or treatment within 30 days of the randomization visit.
* Receiving or scheduled to receive a medication or treatment which, in the opinion of the investigator, was known to interfere with, or affect the rate and quality of wound healing
* Any unstable condition or circumstance that could interfere with treatment regimen compliance
* Excessive lymphedema that could interfere with wound healing
* Unstable Charcot foot or Charcot with boney prominence
* Ulcers secondary to a disease other than diabetes
* Osteomyelitis with necrotic soft bone
* Chopart amputation
* History of bone cancer or metastatic disease of the affected limb, radiation therapy to the foot, or chemotherapy within the 12 months prior to randomization
* Treatment with wound dressings that include growth factors, engineered tissues, or skin substitutes within 30 days of randomization or scheduled to receive such treatment during the study
* Non-study ulcer requiring treatment that could not be treated during the study with moist wound therapy
* History of or intercurrent illnesses or conditions (other than diabetes) that would compromise the safety of the subject, or the normal wound healing process
* Employees or relatives of any member of the investigational site or sponsor
* Size of the study ulcer following debridement decreased by more than 30% during the run in period
18 Years
ALL
No
Sponsors
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Integra LifeSciences Corporation
INDUSTRY
Responsible Party
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Locations
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Costal Clinical Research
Mobile, Alabama, United States
Stockdale Podiatry Group
Bakersfield, California, United States
Center for Clinical Research
Castro Valley, California, United States
Diabetic Foot and Wound Treatment Center
El Centro, California, United States
Sacramento Foot and Ankle Center
Fair Oaks, California, United States
Advanced Foot Care and Clinical Research Center
Fresno, California, United States
Center for Clinical Research
Fresno, California, United States
California School of Podiatry Medicine at Samuel Merritt University
Oakland, California, United States
Northern California Foot and Ankle Center
Santa Rosa, California, United States
Bay Pines VA Healthcare System
Bay Pines, Florida, United States
Advanced Pharma CR, LLC
Miami, Florida, United States
South Florida Wound Care Group
Tamarac, Florida, United States
C/O Center for Wound Care
Wellington, Florida, United States
Village Podiatry Center
Atlanta, Georgia, United States
Idaho Falls Infectious Diseases, PLLC
Idaho Falls, Idaho, United States
Springfield Clinic
Springfield, Illinois, United States
Infectious Disease of Indiana
Indianapolis, Indiana, United States
Benchmark Research
Metarie, Louisiana, United States
Boston Medical Center
Boston, Massachusetts, United States
Cambridge Health Alliance
Cambridge, Massachusetts, United States
Montana Medical Research
Missoula, Montana, United States
Advanced Foot and Ankle Center
Las Vegas, Nevada, United States
Excelsior Foundation of WNY
Amherst, New York, United States
Private Practice
East Setauket, New York, United States
Columbia University Medical Center
New York, New York, United States
Penn North Center For Advanced Wound Care
Erie, Pennsylvania, United States
Temple University School of Podiatric Medicine
Philadelphia, Pennsylvania, United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States
Limb Salvage Center
Dallas, Texas, United States
Department of Plastic Surgery
Dallas, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Foot and Ankle Institute
St. George, Utah, United States
St. Elisabeth's Hospital
Willemstad, Curacao, Netherlands Antilles
Countries
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Other Identifiers
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IDRT/DFU US - 2009-3
Identifier Type: -
Identifier Source: org_study_id
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