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NCT01327937 · ClinicalTrials.gov registry record · Phase 4

A Post Marketing Study of Apligraf in Non-healing Wounds of Subjects With Venous Leg Ulcers

A Phase 4 study of Venous Ulcer, sponsored by Organogenesis.

Completed
Registry status
Phase 4
Development phase
30
Enrollment target
1
Study location

NCT01327937 is a Phase 4 study of Venous Ulcer that has completed, run by Organogenesis. The registered enrollment target is 30 participants, below the 157-participant average among 11 other Venous Ulcer trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01327937, a Phase 4 study of Venous Ulcer, has completed, sponsored by Organogenesis.

COMPLETED
Registry status
Phase 4
Development phase
30 participants
Enrollment target
1
Study location

Study Summary

The overall study objective is to use microarray technology to identify and characterize the gene expression of multiple relevant genes in biopsies of non-healing venous ulcers.

Conditions Studied

Interventions

  • DEVICE Apligraf
  • OTHER Standard of Care Dressing Group

Study Locations (1)

Florida

  • University of Miami - Miami

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2011-03
Est. Completion 2013-12
Phase Phase 4

Sponsor

Organogenesis

20 total trials

What the Registry Record Tells You About NCT01327937

The ClinicalTrials.gov registry entry for NCT01327937 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 157-participant average among 11 other Venous Ulcer trials with a reported enrollment target (81% lower). The listed sponsor is Organogenesis, which has 20 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Venous Ulcer appearing as the primary indexed condition, and to 2 interventions - of which Apligraf is the first listed.

NCT01327937 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.

Frequently Asked Questions

What is clinical trial NCT01327937 about?

NCT01327937 is a clinical study titled "A Post Marketing Study of Apligraf in Non-healing Wounds of Subjects With Venous Leg Ulcers". The overall study objective is to use microarray technology to identify and characterize the gene expression of multiple relevant genes in biopsies of non-healing venous ulcers.

What is the current status of trial NCT01327937?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2011-03. Estimated completion is 2013-12.

What conditions does trial NCT01327937 study?

This clinical trial studies the following conditions: Venous Ulcer.

What interventions are being tested in trial NCT01327937?

The interventions under investigation include: Apligraf (DEVICE), Standard of Care Dressing Group (OTHER).

Who is sponsoring clinical trial NCT01327937?

This trial is sponsored by Organogenesis, which has 20 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01327937 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.