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

Foot Ulcer, Diabetic Clinical Trial

Official title:
A Multi-Center, Prospective, Randomized Study With Primatrix Dermal Repair Scaffold For The Treatment Of Diabetic Foot Ulcers

Clinical Trial Summary

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.

Clinical Trial Description

Subjects will be considered for screening upon meeting initial eligibility criteria. After a 2 week screening period, subject will be randomized and enrolled if additional criteria is met. In particular, if wound size has decreased by greater than 40%, subject will be considered a screen fail and randomization will not take place. If all criteria including wound size at Week 3 is met, subject will be randomized and enrolled. Subjects will return weekly for a maximum of 12 weeks, or whenever healing occurs and then once more for a confirmation of healing. Week 24 will consist of a phone call to the subject to complete QOL surveys. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01270633
Study type Interventional
Source Integra LifeSciences Corporation
Contact
Status Terminated
Phase N/A
Start date December 2010
Completion date September 2017
View Details
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