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NCT00696124 · ClinicalTrials.gov registry record · Phase 1

Safety Study of Gene Therapy in Treating Critical Leg Ischemia

A Phase 1 study of Critical Limb Ischemia, sponsored by Helixmith Co..

Completed
Registry status
Phase 1
Development phase
12
Enrollment target
1
Study location

NCT00696124 is a Phase 1 study of Critical Limb Ischemia that has completed, run by Helixmith Co.. The registered enrollment target is 12 participants, below the 91-participant average among 18 other Critical Limb Ischemia trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00696124, a Phase 1 study of Critical Limb Ischemia, has completed, sponsored by Helixmith Co..

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

Study Summary

The purpose of this study is to determine the safety, tolerability and preliminary efficacy of intramuscular injections of VM202 for subjects with critical limb ischemia. Subjects selected for this study will have critical limb ischemia that has not responded to standard therapy with symptoms including pain at rest and/or ischemic ulcers.

Conditions Studied

Interventions

  • BIOLOGICAL VM202 2 mg
  • BIOLOGICAL VM202 4 mg
  • BIOLOGICAL VM202 8 mg
  • BIOLOGICAL VM202 16 mg

Study Locations (1)

Minnesota

  • Minneapolis Heart Institute Foundation/ Abbott Northwestern Hospital - Minneapolis

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2007-04-03
Est. Completion 2023-12-11
Phase Phase 1

Sponsor

Helixmith Co.

12 total trials

What the Registry Record Tells You About NCT00696124

The ClinicalTrials.gov registry entry for NCT00696124 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 91-participant average among 18 other Critical Limb Ischemia trials with a reported enrollment target (87% lower). The listed sponsor is Helixmith Co., which has 12 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Critical Limb Ischemia appearing as the primary indexed condition, and to 4 interventions - of which VM202 2 mg is the first listed.

NCT00696124 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.

Frequently Asked Questions

What is clinical trial NCT00696124 about?

NCT00696124 is a clinical study titled "Safety Study of Gene Therapy in Treating Critical Leg Ischemia". The purpose of this study is to determine the safety, tolerability and preliminary efficacy of intramuscular injections of VM202 for subjects with critical limb ischemia. Subjects selected for this study will have critical limb ischemia that has not responded to standard therapy with symptoms inclu...

What is the current status of trial NCT00696124?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2007-04-03. Estimated completion is 2023-12-11.

What conditions does trial NCT00696124 study?

This clinical trial studies the following conditions: Critical Limb Ischemia.

What interventions are being tested in trial NCT00696124?

The interventions under investigation include: VM202 2 mg (BIOLOGICAL), VM202 4 mg (BIOLOGICAL), VM202 8 mg (BIOLOGICAL), VM202 16 mg (BIOLOGICAL).

Who is sponsoring clinical trial NCT00696124?

This trial is sponsored by Helixmith Co., which has 12 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00696124 being conducted?

This trial has 1 study location across Minnesota. 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

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