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

Not Applicable

Terminated

• Conditions: Foot Ulcer, Diabetic

• Registration Number: NCT01729286
• Lead Sponsor: Integra LifeSciences Corporation

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.

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-11-13
• Study First Submitted QC: 2012-11-19
• Study First Posted: 2012-11-20
• Primary Completion: 2016-09
• Status Verified: 2016-10
• Study Completion: 2016-10
• Last Update Submitted: 2016-10-14
• Last Update Posted: 2016-10-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 92

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Complete wound closure	by 12 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (18)

University of Southern California; 🇺🇸 Los Angeles, California, United States

Foot and Ankle Clinic; 🇺🇸 Los Angeles, California, United States

Advanced Research Institute of Miami; 🇺🇸 Miami, Florida, United States

Advanced Foot & Ankle Specialists; 🇺🇸 Tampa, Florida, United States

Joseph M. Still Research Foundation; 🇺🇸 Augusta, Georgia, United States

American Health Network; 🇺🇸 Carmel, Indiana, United States

Foot & Andle Center of Mooresville; 🇺🇸 Mooresville, Indiana, United States

Imperial Health; 🇺🇸 Lake Charles, Louisiana, United States

Kansas City Vascular; 🇺🇸 North Kansas City, Missouri, United States

St. Anthony's Medical Center; 🇺🇸 St. Louis, Missouri, United States

Scroll for more (8 remaining)