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Health Economic Assessment of Lower Extremity Diabetic (HEALED) Ulcers With PriMatrix

NCT01729286 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2016-10-18

No results posted yet for this study

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.

Conditions

  • Foot Ulcer, Diabetic

Interventions

DEVICE

PriMatrix Moist Wound Therapy

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

OTHER

Standard of Care Moist Wound Therapy

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

Sponsors & Collaborators

  • Integra LifeSciences Corporation

    lead INDUSTRY

Principal Investigators

  • John Starinski, DPM · TEI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2016-09-30
Completion
2016-10-31

Countries

  • United States
  • Puerto Rico

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 NCT01729286 on ClinicalTrials.gov