Clinical trial NCT01729286: Health Economic Assessment of Lower Extremity Diabetic (HEALED) Ulcers With PriMatrix
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
Overall status: TERMINATED
Phase: NA
Conditions: Foot Ulcer, Diabetic
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
First posted: 2012-11-20
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Complete wound closure
timeFrame: by 12 weeks
Secondary outcomes:
measure: Change in predicted medical expenditures between PriMatrix and Standard of Care
timeFrame: over 24 weeks
measure: Change in quality of life measurements between PriMatrix and Standard of Care
timeFrame: between baseline and 24 weeks
measure: Nonserious and serious adverse events
timeFrame: over 24 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Los Angeles
country: United States
facility: Foot and Ankle Clinic
state: California
city: Miami
country: United States
facility: Advanced Research Institute of Miami
state: Florida
city: Tampa
country: United States
facility: Advanced Foot & Ankle Specialists
state: Florida
city: Augusta
country: United States
facility: Joseph M. Still Research Foundation
state: Georgia
city: Carmel
country: United States
facility: American Health Network
state: Indiana
city: Mooresville
country: United States
facility: Foot & Andle Center of Mooresville
state: Indiana
city: Lake Charles
country: United States
facility: Imperial Health
state: Louisiana
city: North Kansas City
country: United States
facility: Kansas City Vascular
state: Missouri
city: St. Louis
country: United States
facility: St. Anthony's Medical Center
state: Missouri
city: Lake Success
country: United States
facility: North Shore Long Island Jewish Comprehensive Wound Healing Center
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
city: Lancaster
country: United States
facility: Fairfield Medical Center
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Memphis
country: United States
facility: University of Tennessee
state: Tennessee
city: Arecibo
country: Puerto Rico
facility: Centro Podiatrico del Norte
city: Juana Diaz
country: Puerto Rico
facility: Renier Gonzalez-Cruz
city: San Juan
country: Puerto Rico
facility: VA Carribean Healthcare System
Study officials:
affiliation: TEI
name: John Starinski, DPM
role: STUDY_CHAIR
References: