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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: Completed Phase 1 study of Critical Limb Ischemia, sponsored by Helixmith Co..
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Treatment-emergent adverse events defined as adverse events after the first dose of Engensis (Day 1) through Day 365
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
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2007-04-03 |
| Est. Completion | 2023-12-11 |
| Phase | Phase 1 |
What the finished NCT00696124 record still lists
NCT00696124 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 91-participant average among 18 other Critical Limb Ischemia trials with a reported enrollment target (87% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Critical Limb Ischemia
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Where NCT00696124's enrollment target sits among peer trials
12 16th of 18 higher than 3 of 18 other Critical Limb Ischemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Critical Limb Ischemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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