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Safety and Efficacy Study of Engensis (VM202) in the Treatment of Chronic Non-Healing Foot Ulcers

Foot Ulcer, Diabetic Clinical Trial

Official title:
A Phase III, Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Safety and Efficacy of VM202 to Treat Chronic Nonhealing Foot Ulcers in Diabetic Patients With Concomitant Peripheral Arterial Disease (PAD)

Clinical Trial Summary

This study will assess the safety and efficacy of using gene therapy via intramuscular injections of the calf for patients with chronic non-healing foot ulcers.

Clinical Trial Description

A phase III, randomized, double-blind, placebo-controlled, multicenter, 7-month study designed to assess the safety and efficacy of intramuscular (IM) injections in the calf of Engensis (VM202) in patients with chronic nonhealing foot ulcers. Three hundred patients will be randomized in a 2:1 ratio of VM202 or placebo injections: - Active -Engensis (VM202) + standard of care - 200 patients - Control - Placebo (VM202 Vehicle) + standard of care - 100 patients ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02563522
Study type Interventional
Source Helixmith Co., Ltd.
Contact
Status Terminated
Phase Phase 3
Start date June 27, 2017
Completion date September 24, 2019
View Details
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