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

Integra LifeSciences

Status: Terminated

Conditions: Foot Ulcer, Diabetic

Treatments: Device: PriMatrix; Other: Standard of Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT01270633

TEI-004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Treatment

Other group

Description:

PriMatrix applied to appropriately debrided wound bed and covered with a non-adherent dressing. Dressings applied to maintain moist wound therapy.

Treatment:

Device: PriMatrix

Standard of Care

Active Comparator group

Description:

Non adherent dressing applied to appropriately debrided wound bed and moist wound therapy maintained.

Treatment:

Other: Standard of Care