A Study With Primatrix Dermal Repair Scaffold For The Treatment Of Diabetic Foot Ulcers

Stopped early · Not applicable

Conditions studied: Foot Ulcer, Diabetic

In brief

The purpose of this study is to compare the clinical and economic effectiveness of PriMatrix and Standard of Care in the treatment of diabetic foot ulcers (DFUs) in subjects with controlled diabetes mellitus and without significantly compromised arterial circulation.

Key facts

Study ID

NCT01270633

Run by

Integra LifeSciences Corporation

People needed

30

Starts

2010-12-01

Expected to finish

2017-09-01

Last updated by the study team

2017-12-02

Who can join

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

You may qualify if…

• Men or women ≥ 18 years of age and able to give their own consent
• Type I or Type II diabetes with investigator-confirmed reasonable metabolic control
• Study ulcer has a Wagner grade of 1 or 2
• Study ulcer size of at least 1 cm2, but not exceeding 20 cm2 in area after debridement
• A full thickness diabetic foot ulcer located on the foot or ankle
• An ulcer which has been in existence for a minimum of 30 days, prior to the day of screening.

You may not qualify if…

• Suspected or confirmed signs/symptoms of wound infection
• Wounds with exposed bone or tendon
• Hypersensitivity to bovine collagen

Where it is running

• HyperbaRXs — Cumming, Georgia, United States
• Covenant Medical Center — Saginaw, Michigan, United States
• Caribbean Clinical Trials — San Juan, PR, Puerto Rico
• Professional Hospital — Guaynabo, Puerto Rico
• Dr. Pila Metropolitan Hospital Wound Healing Center — Ponce, Puerto Rico
• Doctors' Center Hospital of San Juan — San Juan, Puerto Rico
• Wound and Ulcer Care Clinic of San Juan — San Juan, Puerto Rico
• Wilma N. Vazquez Hospital — Vega Baja, Puerto Rico

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.