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

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.

Study Overview

• Status: Terminated
• Conditions: Foot Ulcer, Diabetic
• Intervention / Treatment: Device: PriMatrix; Other: Standard of Care

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Puerto Rico
  • Guaynabo, Puerto Rico, 00717
    • Professional Hospital
  • Ponce, Puerto Rico, 00717
    • Dr. Pila Metropolitan Hospital Wound Healing Center
  • San Juan, Puerto Rico, 00918
    • Doctors' Center Hospital of San Juan
  • San Juan, Puerto Rico, 00918
    • Wound and Ulcer Care Clinic of San Juan
  • San Juan, Puerto Rico, 00918
    • Caribbean Clinical Trials
  • Vega Baja, Puerto Rico, 00694
    • Wilma N. Vazquez Hospital
• United States
  • Georgia
    • Cumming, Georgia, United States, 30041
      • HyperbaRXs
  • Michigan
    • Saginaw, Michigan, United States, 48602
      • Covenant Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Treatment; PriMatrix applied to appropriately debrided wound bed and covered with a non-adherent dressing. Dressings applied to maintain moist wound therapy.	Device: PriMatrix; Following sharp debridement, application of PriMatrix dermal repair scaffold in conjunction with moist wound therapy
Active Comparator: Standard of Care; Non adherent dressing applied to appropriately debrided wound bed and moist wound therapy maintained.	Other: Standard of Care; Following sharp debridement, moist wound therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of study ulcers healed	Percent of study ulcers healed at week 12 post-randomization	12 weeks post-randomization

Secondary Outcome Measures

Outcome Measure	Time Frame
Cost of Treatment	12 weeks

Collaborators and Investigators

• Sponsor: Integra LifeSciences Corporation
• Investigators: Study Chair: Yiannis Monovoukas, PhD, TEI

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: January 4, 2011
• First Submitted That Met QC Criteria: January 4, 2011
• First Posted (Estimate): January 5, 2011

Study Record Updates

• Last Update Posted (Actual): December 2, 2017
• Last Update Submitted That Met QC Criteria: November 30, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: TEI-004