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

This study has suspended participant recruitment.

(Site selection)

Sponsor:

Information provided by (Responsible Party):

Integra LifeSciences Corporation

ClinicalTrials.gov Identifier:

NCT01270633

First received: January 4, 2011

Last updated: May 15, 2016

Last verified: May 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

January 4, 2011

Last Updated Date

May 15, 2016

Start Date ^ICMJE

December 2010

Estimated Primary Completion Date

September 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Percent of study ulcers healed [ Time Frame: 12 weeks post-randomization ]

Percent of study ulcers healed at week 12 post-randomization

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01270633 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Cost of Treatment [ Time Frame: 12 weeks ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Foot Ulcer, Diabetic

Intervention ^ICMJE

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

Study Arms

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

Intervention: Device: PriMatrix
Active Comparator: Standard of Care
Non adherent dressing applied to appropriately debrided wound bed and moist wound therapy maintained.

Intervention: Other: Standard of Care

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Suspended

Enrollment ^ICMJE

Estimated Completion Date

September 2017

Estimated Primary Completion Date

September 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Puerto Rico, United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01270633

Other Study ID Numbers ^ICMJE

TEI-004

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Integra LifeSciences Corporation

Study Sponsor ^ICMJE

Integra LifeSciences Corporation

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Yiannis Monovoukas, PhD

TEI

PRS Account

Integra LifeSciences Corporation

Verification Date

May 2016

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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