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PriMatrix for the Management of Diabetic Foot Ulcers

NCT03010319 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 226

Last updated 2022-04-29

Study results available
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Summary

The study will evaluate the efficacy of PriMatrix Dermal Repair Scaffold in the management of diabetic foot ulcers in subjects with diabetes mellitus versus the Standard of Care treatment. Half of patients will be treated using PriMatrix while the other half will receive Standard of Care treatment.

Conditions

  • Diabetic Foot Ulcer

Interventions

DEVICE

PriMatrix Dermal Repair Scaffold

Application of PriMatrix to ulcer

DEVICE

Secondary Dressings

Dressings to ensure moist wound environment

DEVICE

Offloading device

Offloading device to decrease pressure to wound area

Sponsors & Collaborators

  • Integra LifeSciences Corporation

    lead INDUSTRY

Principal Investigators

  • John Lantis, MD · The Mount Sinai Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2020-08-31
Completion
2020-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03010319 on ClinicalTrials.gov