NCT07209358

EDX110 Randomized Control Trial for Treatment of DFUs

A Multi-Centre, Observer-Blinded, Randomized Controlled Trial of EDX110 for the Treatment of Diabetic Foot Ulcers

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 298 (estimated)
• Sponsor: ConvaTec Inc. · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Prospective, multi-centered, observer blinded, pre-market study, 1:1 randomized control trial, to determine if addition of EDX110 dressing system to standard of care leads to an improvement in diabetic foot ulcers healing compared to just using standard of care.

Conditions

• Wound Heal
• Diabetic Foot Ulcer

Interventions

Type	Name	Description
DEVICE	EDX110	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: 2025-10-30
• Primary completion: 2026-12-01
• Completion: 2026-12-31
• First posted: 2025-10-07
• Last updated: 2025-12-17

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study