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

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: Completed
• Conditions: Neuropathic Diabetic Ulcer - Foot
• Intervention / Treatment: Device: Integra® Dermal Regeneration Template; Other: Conventional Wound Therapy

• Study Type: Interventional
• Enrollment (Actual): 545
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Complete Wound Closure	100% closure as assessed by the Investigator and confirmed at 2 consecutive treatment phase visits.	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Complete Wound Closure	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	Measures the time to complete wound closure as assessed by the Investigator.	16 weeks
Time to Complete Wound Closure	Time to complete wound closure, as assessed by computerized planimetry.	16 weeks
Rate of Wound Closure	Rate of wound closure as assessed by computerized planimetry	16 weeks
Incidence of Ulcer Recurrence	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	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

• Sponsor: Integra LifeSciences Corporation

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: January 31, 2010
• First Submitted That Met QC Criteria: January 31, 2010
• First Posted (Estimate): February 2, 2010

Study Record Updates

• Last Update Posted (Estimate): September 22, 2016
• Last Update Submitted That Met QC Criteria: July 29, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Diabetic; Wound Healing; Foot Ulcer; Neuropathic; Integra Dermal Regeneration Template; Full Thickness; Omnigraft
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: IDRT/DFU US - 2009-3