CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 52 enrolled
Drug / intervention
Low Dose VM202 +2 morebiological
Likely dose
Low Dose VM202 4mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01064440
NCT01064440Phase 2Completed
CompareCT.gov

A Phase II, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of VM202 (Engensis) in Subject With Critical Limb Ischemia

Helixmith Co., Ltd.·interventional·Posted Feb 8, 2010·Updated Oct 6, 2025

In Brief

A Phase 2 clinical trial evaluating Low Dose VM202, High Dose VM202, and 1 other intervention for Critical Limb Ischemia. Completed, enrolled 52 participants across 16 sites in 2 countries.

Detailed Summary

The purpose of this study is to evaluate whether intramuscular injections of VM202 into the calf is safe and effective in the treatment of critical limb ischemia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCritical Limb Ischemia
CountriesSouth Korea, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 8, 2010
Enrollment StartJul 9, 2010
Primary CompletionAug 5, 2013
Study CompletionNov 17, 2023
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 16.4 years ago

Interventions

Low Dose VM202biological

Day 0: 4mg of VM202 (16 injections of 0.5ml of VM202) Day14: 4mg of VM202 (16 injections of 0.5ml of VM202)

High Dose VM202biological

Day 0: 4mg of VM202 (16 injections of 0.5ml of VM202) Day 14: 4mg of VM202 (16 injections of 0.5ml of VM202) Day 28: 4mg of VM202 (16 injections of 0.5ml of VM202) Day 42: 4mg of VM202 (16 injections of 0.5ml of VM202)

Placeboother

Day 0: 16 injections of 0.5ml of normal saline Day 14: 16 injections of 0.5ml of normal saline Day 28: 16 injections of 0.5ml of normal saline Day 42: 16 injections of 0.5ml of normal saline