NCT02563522

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

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)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Helixmith Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Foot Ulcer, Diabetic

Interventions

Type	Name	Description
GENETIC	Engensis (VM202)	gene therapy
DRUG	Placebo	Standard of care plus placebo

Timeline

• Start date: 2017-06-27
• Primary completion: 2019-09-24
• Completion: 2019-09-24
• First posted: 2015-09-30
• Last updated: 2025-10-09
• Results posted: 2023-02-22

Locations

22 sites across 1 country: United States

Regulatory

• FDA-regulated drug study