NCT01729286

Brief Summary

The objective of this study is to compare the effectiveness of PriMatrix Moist Wound Therapy (MWT) with Standard of Care MWT for the treatment of chronic diabetic foot ulcers in subjects with diabetes mellitus and without significantly compromised arterial circulation.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable

Geographic Reach
2 countries

18 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 20, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 18, 2016

Status Verified

October 1, 2016

Enrollment Period

4 years

First QC Date

November 13, 2012

Last Update Submit

October 14, 2016

Conditions

Foot Ulcer, Diabetic

Outcome Measures

Primary Outcomes (1)

  • Complete wound closure

    by 12 weeks

Secondary Outcomes (3)

  • Change in predicted medical expenditures between PriMatrix and Standard of Care

    over 24 weeks

  • Change in quality of life measurements between PriMatrix and Standard of Care

    between baseline and 24 weeks

  • Nonserious and serious adverse events

    over 24 weeks

Study Arms (2)

PriMatrix Moist Wound Therapy

ACTIVE COMPARATOR

sharp debridement, Primatrix, a dressing regimen that maintains a moist wound healing environment, and offloading

Device: PriMatrix Moist Wound TherapyOther: Standard of Care Moist Wound Therapy

Standard of Care Moist Wound Therapy

OTHER

sharp debridement, a dressing regimen that maintains a moist wound healing environment, and offloading

Other: Standard of Care Moist Wound Therapy

Interventions

PriMatrix Moist Wound TherapyDEVICE

sharp debridement, PriMatrix, a dressing regimen that maintains a moist wound healing environment, and offloading

Also known as: PriMatrix Dermal Repair Scaffold
PriMatrix Moist Wound Therapy
Standard of Care Moist Wound TherapyOTHER

sharp debridement, a dressing regimen that maintains a moist wound healing environment, and offloading

PriMatrix Moist Wound TherapyStandard of Care Moist Wound Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type I or Type II diabetes
  • A diabetic foot ulcer located on the foot or ankle at least one square centimeter

You may not qualify if:

  • Suspected or confirmed signs/symptoms of wound infection
  • Hypersensitivity to bovine collagen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

University of Southern California

Los Angeles, California, 90033, United States

Location

Foot and Ankle Clinic

Los Angeles, California, 90057, United States

Location

Advanced Research Institute of Miami

Miami, Florida, 33030, United States

Location

Advanced Foot & Ankle Specialists

Tampa, Florida, 33606, United States

Location

Joseph M. Still Research Foundation

Augusta, Georgia, 30909, United States

Location

American Health Network

Carmel, Indiana, 46032, United States

Location

Foot & Andle Center of Mooresville

Mooresville, Indiana, 46158, United States

Location

Imperial Health

Lake Charles, Louisiana, 70601, United States

Location

Kansas City Vascular

North Kansas City, Missouri, 64116, United States

Location

St. Anthony's Medical Center

St Louis, Missouri, 63128, United States

Location

North Shore Long Island Jewish Comprehensive Wound Healing Center

Lake Success, New York, 11042, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

Fairfield Medical Center

Lancaster, Ohio, 43130, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Tennessee

Memphis, Tennessee, 38103, United States

Location

Centro Podiatrico del Norte

Arecibo, 00612, Puerto Rico

Location

Renier Gonzalez-Cruz

Juana Díaz, 00795, Puerto Rico

Location

VA Carribean Healthcare System

San Juan, 00921, Puerto Rico

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Study Officials

  • John Starinski, DPM

    TEI

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2012

First Posted

November 20, 2012

Study Start

September 1, 2012

Primary Completion

September 1, 2016

Study Completion

October 1, 2016

Last Updated

October 18, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

US(15)PR(3)