NCT01228526

Brief Summary

To evaluate the effectiveness of PriMatrix in the treatment of DFUs in subjects without significantly compromised arterial circulation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2010

Typical duration for all trials

Geographic Reach
1 country

5 active sites

Status
completed

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

August 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 26, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

August 26, 2016

Status Verified

August 1, 2016

Enrollment Period

2.1 years

First QC Date

October 25, 2010

Last Update Submit

August 25, 2016

Conditions

Foot Ulcers, Diabetic

Outcome Measures

Primary Outcomes (1)

  • Percent of study ulcers healed

    Week 12

Interventions

PriMatrixDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a diabetic foot ulcer and meet the inclusion/exclusion criteria

You may qualify if:

  • Type I or Type II diabetes with investigator-confirmed reasonable metabolic control
  • Peripheral neuropathy
  • A full thickness diabetic plantar foot ulcer of at least 1 cm2 but not exceeding 10 cm2 in area
  • An ulcer which has been in existence for a minimum of 30 days, prior to the day of screening

You may not qualify if:

  • Suspected or confirmed signs/symptoms of wound infection
  • Wounds with exposed bone or tendon
  • Hypersensitivity to bovine collagen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

California School of Podiatric Medicine at Samuel Merritt University

Oakland, California, 94609, United States

Location

Mayo Clinic

Rochester, Minnesota, United States

Location

New York College of Podiatric Medicine

New York, New York, 10035, United States

Location

Circleville Foot & Ankle

Circleville, Ohio, 43113, United States

Location

Temple University School of Podiatric Medicine

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Foot Ulcer

Condition Hierarchy (Ancestors)

Foot DiseasesSkin DiseasesSkin and Connective Tissue DiseasesLeg UlcerSkin Ulcer

Study Officials

  • Steven Kavros, DPM

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2010

First Posted

October 26, 2010

Study Start

August 1, 2010

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

August 26, 2016

Record last verified: 2016-08

Locations

US(5)