NCT03110796

Assessment of the Efficacy and Safety of a New Medical Device in the Local Treatment of Diabetic Foot Ulcers

Assessment of the Efficacy and Safety of a New Medical Device in the Local Treatment of Diabetic Foot Ulcers: a Prospective, Randomized, Controlled, Double-blind, European Multicentre Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: Laboratoires URGO · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Evaluation of the efficacy and safety of a device with LU3103209 compound versus the same device, free of LU3103209 compound, in the local management of DFUs.

Detailed description

A European prospective, randomized, double-blind, multicentre, clinical trial, conducted in three parallel groups, to evaluate the efficacy and safety of a device with LU3103209 compound versus the same device, free of LU3103209 compound, in the local management of diabetic foot ulcers (DFUs).

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
DEVICE	Dressing with LU3103209 - Dose 1	Dressing with LU3103209 - Dose 1
DEVICE	Dressing with LU3103209 - Dose 2	Dressing with LU3103209 - Dose 2
DEVICE	Dressing without LU3103209	Dressing without LU3103209

Timeline

• Start date: 2017-07-31
• Primary completion: 2020-01-01
• Completion: 2020-01-01
• First posted: 2017-04-12
• Last updated: 2019-01-17

Locations

6 sites across 6 countries: Czechia, France, Italy, Poland, Spain, United Kingdom