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

Primary Purpose

Foot Ulcer, Diabetic

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
PriMatrix Moist Wound Therapy
Standard of Care Moist Wound Therapy
Sponsored by
Integra LifeSciences Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Foot Ulcer, Diabetic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Southern California
  • Foot and Ankle Clinic
  • Advanced Research Institute of Miami
  • Advanced Foot & Ankle Specialists
  • Joseph M. Still Research Foundation
  • American Health Network
  • Foot & Andle Center of Mooresville
  • Imperial Health
  • Kansas City Vascular
  • St. Anthony's Medical Center
  • North Shore Long Island Jewish Comprehensive Wound Healing Center
  • Wake Forest University
  • Fairfield Medical Center
  • University of Pittsburgh Medical Center
  • University of Tennessee
  • Centro Podiatrico del Norte
  • Renier Gonzalez-Cruz
  • VA Carribean Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

PriMatrix Moist Wound Therapy

Standard of Care Moist Wound Therapy

Arm Description

sharp debridement, Primatrix, a dressing regimen that maintains a moist wound healing environment, and offloading

sharp debridement, a dressing regimen that maintains a moist wound healing environment, and offloading

Outcomes

Primary Outcome Measures

Complete wound closure

Secondary Outcome Measures

Change in predicted medical expenditures between PriMatrix and Standard of Care
Change in quality of life measurements between PriMatrix and Standard of Care
Nonserious and serious adverse events

Full Information

First Posted
November 13, 2012
Last Updated
October 14, 2016
Sponsor
Integra LifeSciences Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01729286
Brief Title
Health Economic Assessment of Lower Extremity Diabetic (HEALED) Ulcers With PriMatrix
Acronym
HEALED
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Terminated
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Integra LifeSciences Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foot Ulcer, Diabetic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PriMatrix Moist Wound Therapy
Arm Type
Active Comparator
Arm Description
sharp debridement, Primatrix, a dressing regimen that maintains a moist wound healing environment, and offloading
Arm Title
Standard of Care Moist Wound Therapy
Arm Type
Other
Arm Description
sharp debridement, a dressing regimen that maintains a moist wound healing environment, and offloading
Intervention Type
Device
Intervention Name(s)
PriMatrix Moist Wound Therapy
Other Intervention Name(s)
PriMatrix Dermal Repair Scaffold
Intervention Description
sharp debridement, PriMatrix, a dressing regimen that maintains a moist wound healing environment, and offloading
Intervention Type
Other
Intervention Name(s)
Standard of Care Moist Wound Therapy
Intervention Description
sharp debridement, a dressing regimen that maintains a moist wound healing environment, and offloading
Primary Outcome Measure Information:
Title
Complete wound closure
Time Frame
by 12 weeks
Secondary Outcome Measure Information:
Title
Change in predicted medical expenditures between PriMatrix and Standard of Care
Time Frame
over 24 weeks
Title
Change in quality of life measurements between PriMatrix and Standard of Care
Time Frame
between baseline and 24 weeks
Title
Nonserious and serious adverse events
Time Frame
over 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Starinski, DPM
Organizational Affiliation
TEI
Official's Role
Study Chair
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Foot and Ankle Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Advanced Research Institute of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33030
Country
United States
Facility Name
Advanced Foot & Ankle Specialists
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Joseph M. Still Research Foundation
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
American Health Network
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
Foot & Andle Center of Mooresville
City
Mooresville
State/Province
Indiana
ZIP/Postal Code
46158
Country
United States
Facility Name
Imperial Health
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
Kansas City Vascular
City
North Kansas City
State/Province
Missouri
ZIP/Postal Code
64116
Country
United States
Facility Name
St. Anthony's Medical Center
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
North Shore Long Island Jewish Comprehensive Wound Healing Center
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Fairfield Medical Center
City
Lancaster
State/Province
Ohio
ZIP/Postal Code
43130
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
University of Tennessee
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Facility Name
Centro Podiatrico del Norte
City
Arecibo
ZIP/Postal Code
00612
Country
Puerto Rico
Facility Name
Renier Gonzalez-Cruz
City
Juana Diaz
ZIP/Postal Code
00795
Country
Puerto Rico
Facility Name
VA Carribean Healthcare System
City
San Juan
ZIP/Postal Code
00921
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
No

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

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