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

Stopped early · Not applicable

Conditions studied: Foot Ulcer, Diabetic

In brief

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.

Key facts

Study ID

NCT01729286

Run by

Integra LifeSciences Corporation

People needed

92

Starts

2012-09-01

Expected to finish

2016-10-01

Last updated by the study team

2016-10-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Type I or Type II diabetes
• A diabetic foot ulcer located on the foot or ankle at least one square centimeter

You may not qualify if…

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

Where it is running

• 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
• North Shore Long Island Jewish Comprehensive Wound Healing Center — Lake Success, New York, United States
• Wake Forest University — Winston-Salem, North Carolina, United States
• Fairfield Medical Center — Lancaster, Ohio, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• University of Tennessee — Memphis, Tennessee, United States
• Centro Podiatrico del Norte — Arecibo, Puerto Rico
• Renier Gonzalez-Cruz — Juana Diaz, Puerto Rico
• VA Carribean Healthcare System — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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