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

Not Applicable

Terminated

• Conditions: Foot Ulcer, Diabetic
• Interventions: Other: Standard of Care; Device: PriMatrix

• Registration Number: NCT01270633
• Lead Sponsor: Integra LifeSciences Corporation

Brief 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.

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-01-04
• Study First Submitted QC: 2011-01-04
• Study First Posted: 2011-01-05
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-30
• Last Update Posted: 2017-12-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care	Standard of Care	Non adherent dressing applied to appropriately debrided wound bed and moist wound therapy maintained.
Treatment	PriMatrix	PriMatrix applied to appropriately debrided wound bed and covered with a non-adherent dressing. Dressings applied to maintain moist wound therapy.

Primary Outcome Measures

Name	Time	Method
Percent of study ulcers healed	12 weeks post-randomization	Percent of study ulcers healed at week 12 post-randomization

Secondary Outcome Measures

Name	Time	Method
Cost of Treatment	12 weeks

Trial Locations

Locations (8)

Covenant Medical Center; 🇺🇸 Saginaw, Michigan, United States

Professional Hospital; 🇵🇷 Guaynabo, Puerto Rico

Wound and Ulcer Care Clinic of San Juan; 🇵🇷 San Juan, Puerto Rico

Caribbean Clinical Trials; 🇵🇷 San Juan, Puerto Rico

HyperbaRXs; 🇺🇸 Cumming, Georgia, United States

Dr. Pila Metropolitan Hospital Wound Healing Center; 🇵🇷 Ponce, Puerto Rico

Wilma N. Vazquez Hospital; 🇵🇷 Vega Baja, Puerto Rico

Doctors' Center Hospital of San Juan; 🇵🇷 San Juan, Puerto Rico