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

July 29, 2016 updated by: Integra LifeSciences Corporation

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
545

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of Complete Wound Closure
Time Frame: 16 weeks
100% closure as assessed by the Investigator and confirmed at 2 consecutive treatment phase visits.
16 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
16 weeks
Time to Complete Wound Closure
Time Frame: 16 weeks
Measures the time to complete wound closure as assessed by the Investigator.
16 weeks
Time to Complete Wound Closure
Time Frame: 16 weeks
Time to complete wound closure, as assessed by computerized planimetry.
16 weeks
Rate of Wound Closure
Time Frame: 16 weeks
Rate of wound closure as assessed by computerized planimetry
16 weeks
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.
12 weeks
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.
Baseline and 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Integra LifeSciences Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 31, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 2, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IDRT/DFU US - 2009-3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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