NCT06640985

EDX110 - Efficacy and Safety in the Management of Hard-to-heal Wounds

A Single-center Prospective Case Series Study to Determine the Efficacy and Safety of EDX110 in Hard-to-heal Wounds Resulting From Venous Insufficiency or Diabetes

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: ConvaTec Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Post-market study to determine the efficacy of EDX110 dressing system in hard-to-heal wounds.

Detailed description

Prospective, single-center, non-blinded, non-randomized, post-market study to determine the efficacy of EDX110 dressing system in diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs).

Conditions

• Wound Healing
• Diabetic Foot
• Foot Ulcer, Diabetic
• Venous Ulcer

Interventions

Type	Name	Description
DEVICE	EDX110 wound dressing system	EDX110 is a dressing system comprising two layers that allows the generation of nitric oxide (NO) in situ, enables adequate moisture management and facilitates debridement

Timeline

• Start date: 2024-12-04
• Primary completion: 2026-02-01
• Completion: 2026-02-01
• First posted: 2024-10-15
• Last updated: 2025-12-23

Locations

1 site across 1 country: Chile