A Multicenter, Prospective, Observational Study With PriMatrix for the Treatment of Neuropathic Diabetic Foot Ulcers

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01228526

Enrollment

Registered

2010-10-26

Start date

2010-08-31

Completion date

2012-09-30

Last updated

2016-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Foot Ulcers, Diabetic

Brief summary

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

Interventions

DEVICEPriMatrix

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Percent of study ulcers healed	Week 12

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026