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

NCT ID: NCT01270633

Last Updated: 2017-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2017-09-30

Brief Summary

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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

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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

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Foot Ulcer, Diabetic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

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

Group Type OTHER

PriMatrix

Intervention Type DEVICE

Following sharp debridement, application of PriMatrix dermal repair scaffold in conjunction with moist wound therapy

Standard of Care

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

Group Type ACTIVE_COMPARATOR

Standard of Care

Intervention Type OTHER

Following sharp debridement, moist wound therapy

Interventions

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PriMatrix

Following sharp debridement, application of PriMatrix dermal repair scaffold in conjunction with moist wound therapy

Intervention Type DEVICE

Standard of Care

Following sharp debridement, moist wound therapy

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Integra LifeSciences Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yiannis Monovoukas, PhD

Role: STUDY_CHAIR

TEI

Locations

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HyperbaRXs

Cumming, Georgia, United States

Site Status

Covenant Medical Center

Saginaw, Michigan, United States

Site Status

Caribbean Clinical Trials

San Juan, PR, Puerto Rico

Site Status

Professional Hospital

Guaynabo, , Puerto Rico

Site Status

Dr. Pila Metropolitan Hospital Wound Healing Center

Ponce, , Puerto Rico

Site Status

Doctors' Center Hospital of San Juan

San Juan, , Puerto Rico

Site Status

Wound and Ulcer Care Clinic of San Juan

San Juan, , Puerto Rico

Site Status

Wilma N. Vazquez Hospital

Vega Baja, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

Other Identifiers

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TEI-004

Identifier Type: -

Identifier Source: org_study_id