Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Trial of VLTS-934 in Subjects With Intermittent Claudication Secondary to Peripheral Arterial Disease
NCT00113009 · View on ClinicalTrials.gov ↗
Study Summary
This is a phase II, multicenter, randomized, double-blind, placebo-controlled trial in which subjects with intermittent claudication (IC) will be randomized to receive a single treatment of VLTS-934 (84 mL, or a total of 420 mg poloxamer 188) or placebo (84 mL saline) administered as 21 intramuscular (IM) injections of 2 mL each, bilaterally into the lower extremities during one procedure to evaluate the safety, tolerability, and potential activity of VLTS-934 as compared with a saline placebo.
Conditions Studied
Interventions
- DRUG VLTS-934
Study Locations (20)
Florida
- — Deerfield Beach
- — DeLand
- — Jacksonville
- — Melbourne
- — Sarasota
California
- — Beverly Hills
- — Los Angeles
- — Mountain View
- — Santa Rosa
Louisiana
- — Houma
- — Thibodaux
Michigan
- University of Michigan Health Systems — Ann Arbor
- — Flint
Alabama
- — Birmingham
Georgia
- — Atlanta
Illinois
- — Chicago
Maine
- — Auburn
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 148 participants |
| Start Date | 2005-03 |
| Est. Completion | 2006-07 |
| Phase | Phase 2 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00113009
The ClinicalTrials.gov registry entry for NCT00113009 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 148 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Valentis, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Peripheral Vascular Disease appearing as the primary indexed condition, and to 1 intervention — of which VLTS-934 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00113009 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Florida, California, Louisiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00113009 about?
NCT00113009 is a clinical study titled "Trial of VLTS-934 in Subjects With Intermittent Claudication Secondary to Peripheral Arterial Disease". This is a phase II, multicenter, randomized, double-blind, placebo-controlled trial in which subjects with intermittent claudication (IC) will be randomized to receive a single treatment of VLTS-934 (84 mL, or a total of 420 mg poloxamer 188) or placebo (84 mL saline) administered as 21 intramuscula...
What is the current status of trial NCT00113009?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 148 participants. The study started on 2005-03. Estimated completion is 2006-07.
What conditions does trial NCT00113009 study?
This clinical trial studies the following conditions: Peripheral Vascular Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00113009?
The interventions under investigation include: VLTS-934 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00113009?
This trial is sponsored by Valentis, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00113009 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.