Health Economic Assessment of Lower Extremity Diabetic (HEALED) Ulcers With PriMatrix (HEALED)

A Multi-Center, Prospective, Randomized Study With PriMatrix Dermal Repair Scaffold Moist Wound Therapy and Standard of Care Moist Wound Therapy for the Treatment of Chronic Diabetic Foot Ulcers

The objective of this study is to compare the effectiveness of PriMatrix Moist Wound Therapy (MWT) with Standard of Care MWT for the treatment of chronic diabetic foot ulcers in subjects with diabetes mellitus and without significantly compromised arterial circulation.

Study Overview

• Status: Terminated
• Conditions: Foot Ulcer, Diabetic
• Intervention / Treatment: Device: PriMatrix Moist Wound Therapy; Other: Standard of Care Moist Wound Therapy

Detailed Description

This study will be a multi-center, prospective, randomized single-blinded study evaluating the efficacy of PriMatrix MWT versus Standard of Care MWT in achieving complete wound closure of chronic diabetic foot ulcers by 12 weeks (84 days). To measure wound recidivism and changes in functional quality of life, each subject will complete the Cardiff Wound Impact Schedule and the SF-36v2™ at three time points during the study i) at initial screening, ii) at completion of treatment phase, and iii)at 24 weeks (post-randomization). Additionally, the data obtained from the SF-36v2™ will be used in an economic evaluation of the treatment arms.

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Puerto Rico
  • Arecibo, Puerto Rico, 00612
    • Centro Podiatrico del Norte
  • Juana Diaz, Puerto Rico, 00795
    • Renier Gonzalez-Cruz
  • San Juan, Puerto Rico, 00921
    • VA Carribean Healthcare System
• United States
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California
    • Los Angeles, California, United States, 90057
      • Foot and Ankle Clinic
  • Florida
    • Miami, Florida, United States, 33030
      • Advanced Research Institute of Miami
    • Tampa, Florida, United States, 33606
      • Advanced Foot & Ankle Specialists
  • Georgia
    • Augusta, Georgia, United States, 30909
      • Joseph M. Still Research Foundation
  • Indiana
    • Carmel, Indiana, United States, 46032
      • American Health Network
    • Mooresville, Indiana, United States, 46158
      • Foot & Andle Center of Mooresville
  • Louisiana
    • Lake Charles, Louisiana, United States, 70601
      • Imperial Health
  • Missouri
    • North Kansas City, Missouri, United States, 64116
      • Kansas City Vascular
    • St. Louis, Missouri, United States, 63128
      • St. Anthony's Medical Center
  • New York
    • Lake Success, New York, United States, 11042
      • North Shore Long Island Jewish Comprehensive Wound Healing Center
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University
  • Ohio
    • Lancaster, Ohio, United States, 43130
      • Fairfield Medical Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • Tennessee
    • Memphis, Tennessee, United States, 38103
      • University of Tennessee

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
• A diabetic foot ulcer located on the foot or ankle at least one square centimeter

Exclusion Criteria:

• Suspected or confirmed signs/symptoms of wound infection
• Hypersensitivity to bovine collagen

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PriMatrix Moist Wound Therapy; sharp debridement, Primatrix, a dressing regimen that maintains a moist wound healing environment, and offloading	Device: PriMatrix Moist Wound Therapy; sharp debridement, PriMatrix, a dressing regimen that maintains a moist wound healing environment, and offloading; Other Names: PriMatrix Dermal Repair Scaffold; Other: Standard of Care Moist Wound Therapy; sharp debridement, a dressing regimen that maintains a moist wound healing environment, and offloading
Other: Standard of Care Moist Wound Therapy; sharp debridement, a dressing regimen that maintains a moist wound healing environment, and offloading	Other: Standard of Care Moist Wound Therapy; sharp debridement, a dressing regimen that maintains a moist wound healing environment, and offloading

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Complete wound closure	by 12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in predicted medical expenditures between PriMatrix and Standard of Care	over 24 weeks
Change in quality of life measurements between PriMatrix and Standard of Care	between baseline and 24 weeks
Nonserious and serious adverse events	over 24 weeks

Collaborators and Investigators

• Sponsor: Integra LifeSciences Corporation
• Investigators: Study Chair: John Starinski, DPM, TEI

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: November 13, 2012
• First Submitted That Met QC Criteria: November 19, 2012
• First Posted (Estimate): November 20, 2012

Study Record Updates

• Last Update Posted (Estimate): October 18, 2016
• Last Update Submitted That Met QC Criteria: October 14, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• 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: TEI-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO