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Efficacy and Safety of Artacent™ for Treatment Resistant Lower Extremity Venous and Diabetic Ulcers

NCT02838784 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2017-10-13

No results posted yet for this study

Summary

This study will compare the proportion of patients who have wound closure within 12 weeks as well as the time to wound closure in patients receiving Artacent™ versus standard of care for treatment of non-healing lower extremity wounds. The recurrence of healed wounds will be assessed at 6 months via a telephone survey

Conditions

  • Venous Ulcer
  • Foot Ulcer, Diabetic

Interventions

OTHER

Artacent Human Amniotic Membrane

Double layer dehydrated amnion product

PROCEDURE

Standard of Care

Off loading with a cast walker, non-adherent dressings, debridement and moisture retentive dressings

Sponsors & Collaborators

  • Tides Medical

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2018-12-31
Completion
2018-12-31

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 NCT02838784 on ClinicalTrials.gov