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
1 other identifier
interventional
545
2 countries
33
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2010
Longer than P75 for not_applicable
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2010
CompletedFirst Posted
Study publicly available on registry
February 2, 2010
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedResults Posted
Study results publicly available
September 22, 2016
CompletedSeptember 22, 2016
July 1, 2016
4.2 years
January 31, 2010
March 23, 2016
July 29, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Complete Wound Closure
100% closure as assessed by the Investigator and confirmed at 2 consecutive treatment phase visits.
16 weeks
Secondary Outcomes (6)
Incidence of Complete Wound Closure
16 weeks
Time to Complete Wound Closure
16 weeks
Time to Complete Wound Closure
16 weeks
Rate of Wound Closure
16 weeks
Incidence of Ulcer Recurrence
12 weeks
- +1 more secondary outcomes
Study Arms (2)
Dermal Replacement Device
EXPERIMENTALDevice: INTEGRA® Dermal Regeneration Template
Moist Wound Therapy
ACTIVE COMPARATOR0.9% Saline gel
Interventions
Application of Integra® Dermal Regeneration Template in diabetic foot ulcer
Eligibility Criteria
You may qualify if:
- 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:
- 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),
- Minimum 2-cm margin between the qualifying study ulcer and any other ulcers on the specified foot (post debridement),
- 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),
- Wagner grade 1 or 2,
- Depth less than or equal to 5 millimeters with no exposed capsule, tendon or bone and no tunneling, undermining or sinus tracts,
- Duration of the study ulcer was at least 30 days at the time of the screening visit
- Adequate vascular perfusion of the affected limb
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
Costal Clinical Research
Mobile, Alabama, 36608, United States
Stockdale Podiatry Group
Bakersfield, California, 93309, United States
Center for Clinical Research
Castro Valley, California, 94546, United States
Diabetic Foot and Wound Treatment Center
El Centro, California, 92243, United States
Sacramento Foot and Ankle Center
Fair Oaks, California, 95628, United States
Advanced Foot Care and Clinical Research Center
Fresno, California, 93722, United States
Center for Clinical Research
Fresno, California, 94115, United States
California School of Podiatry Medicine at Samuel Merritt University
Oakland, California, 94609, United States
Northern California Foot and Ankle Center
Santa Rosa, California, 95403, United States
Bay Pines VA Healthcare System
Bay Pines, Florida, 33744, United States
Advanced Pharma CR, LLC
Miami, Florida, 33136, United States
South Florida Wound Care Group
Tamarac, Florida, 33321, United States
C/O Center for Wound Care
Wellington, Florida, 33414, United States
Village Podiatry Center
Atlanta, Georgia, 30308, United States
Idaho Falls Infectious Diseases, PLLC
Idaho Falls, Idaho, 83404, United States
Springfield Clinic
Springfield, Illinois, 62703, United States
Infectious Disease of Indiana
Indianapolis, Indiana, 46260, United States
Benchmark Research
Metarie, Louisiana, 70006, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Cambridge Health Alliance
Cambridge, Massachusetts, 02139, United States
Montana Medical Research
Missoula, Montana, 59808, United States
Advanced Foot and Ankle Center
Las Vegas, Nevada, 89119, United States
Excelsior Foundation of WNY
Amherst, New York, 14226, United States
Private Practice
East Setauket, New York, 11733, United States
Columbia University Medical Center
New York, New York, 10034, United States
Penn North Center For Advanced Wound Care
Erie, Pennsylvania, 16544, United States
Temple University School of Podiatric Medicine
Philadelphia, Pennsylvania, 19107, United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224, United States
Limb Salvage Center
Dallas, Texas, 75231, United States
Department of Plastic Surgery
Dallas, Texas, 75390, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Foot and Ankle Institute
St. George, Utah, 84770, United States
St. Elisabeth's Hospital
Willemstad, Curacao, Netherlands Antilles
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Katie Bush, PhD- Manager, Global Medical Affairs- Tissue Technology
- Organization
- Integra LifeSciences, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2010
First Posted
February 2, 2010
Study Start
April 1, 2010
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
September 22, 2016
Results First Posted
September 22, 2016
Record last verified: 2016-07