NCT01270633

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Integra LifeSciences Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Foot Ulcer, Diabetic

Interventions

Type	Name	Description
DEVICE	PriMatrix	Following sharp debridement, application of PriMatrix dermal repair scaffold in conjunction with moist wound therapy
OTHER	Standard of Care	Following sharp debridement, moist wound therapy

Timeline

• Start date: 2010-12-01
• Primary completion: 2017-09-01
• Completion: 2017-09-01
• First posted: 2011-01-05
• Last updated: 2017-12-02

Locations

8 sites across 2 countries: United States, Puerto Rico