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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01060670
Recruitment Status : Completed
First Posted : February 2, 2010
Results First Posted : September 22, 2016
Last Update Posted : September 22, 2016
Information provided by (Responsible Party):
Integra LifeSciences Corporation

Brief Summary:
The objective of this study is to evaluate the safety and efficacy 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 or disease Intervention/treatment Phase
Neuropathic Diabetic Ulcer - Foot Device: Integra® Dermal Regeneration Template Other: Conventional Wound Therapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 545 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2010
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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
0.9% Saline gel
Other: Conventional Wound Therapy
Conventional Wound Therapy

Primary Outcome Measures :
  1. Incidence of Complete Wound Closure [ Time Frame: 16 weeks ]
    100% closure as assessed by the Investigator and confirmed at 2 consecutive treatment phase visits.

Secondary Outcome Measures :
  1. Incidence of Complete Wound Closure [ Time Frame: 16 weeks ]
    Percentage of subjects with complete wound closure of the study ulcer, as assessed by computerized planimetry, during the treatment phase.

  2. Time to Complete Wound Closure [ Time Frame: 16 weeks ]
    Measures the time to complete wound closure as assessed by the Investigator.

  3. Time to Complete Wound Closure [ Time Frame: 16 weeks ]
    Time to complete wound closure, as assessed by computerized planimetry.

  4. Rate of Wound Closure [ Time Frame: 16 weeks ]
    Rate of wound closure as assessed by computerized planimetry

  5. Incidence of Ulcer Recurrence [ Time Frame: 12 weeks ]
    Measures the incidence of ulcer recurrence at the site of the study ulcer during the follow up phase.

  6. Change in Short Form Health Survey (SF-36) Quality of Life Metrics [ Time Frame: Baseline and 16 weeks ]
    Short Form Health Survey (SF-36)- Quality of Life Metrics. The SF-36 was utilized and the Physical Function and Bodily Pain subscales were norm-based, with a Mean = 50, SD = 10. Scores could theoretically range from 0 to 100, with higher scores indicating a better health status.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Type I or Type II diabetes mellitus
  • 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:

  • Suspected or confirmed signs/symptoms of gangrene or wound infection on any part of the limb
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01060670

  Hide Study 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

Responsible Party: Integra LifeSciences Corporation Identifier: NCT01060670     History of Changes
Other Study ID Numbers: IDRT/DFU US - 2009-3
First Posted: February 2, 2010    Key Record Dates
Results First Posted: September 22, 2016
Last Update Posted: September 22, 2016
Last Verified: July 2016

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

Additional relevant MeSH terms:
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