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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: July 29, 2016
Last verified: July 2016
  Purpose
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 Intervention
Neuropathic Diabetic Ulcer - Foot
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 ]
    100% closure as assessed by the Investigator and confirmed at 2 consecutive treatment phase visits.


Secondary Outcome Measures:
  • Incidence of Complete Wound Closure [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Percentage of subjects with complete wound closure of the study ulcer, as assessed by computerized planimetry, during the treatment phase.

  • Time to Complete Wound Closure [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Measures the time to complete wound closure as assessed by the Investigator.

  • Time to Complete Wound Closure [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Time to complete wound closure, as assessed by computerized planimetry.

  • Rate of Wound Closure [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Rate of wound closure as assessed by computerized planimetry

  • Incidence of Ulcer Recurrence [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Measures the incidence of ulcer recurrence at the site of the study ulcer during the follow up phase.

  • Change in Short Form Health Survey (SF-36) Quality of Life Metrics [ Time Frame: Baseline and 16 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 545
Study Start Date: April 2010
Study Completion Date: June 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
0.9% Saline gel
Other: Conventional Wound Therapy
Conventional Wound Therapy

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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

  Show 33 Study Locations
Sponsors and Collaborators
Integra LifeSciences Corporation
  More Information

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
Results First Received: March 23, 2016
Last Updated: July 29, 2016
Health Authority: United States: Food and Drug Administration

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

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 December 02, 2016