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ACTIVE NOT RECRUITING
NCT07209358
NA

EDX110 Randomized Control Trial for Treatment of DFUs

Sponsor: ConvaTec Inc.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2025-10-30

Completion Date

2027-06-30

Last Updated

2026-11-02

Healthy Volunteers

No

Interventions

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

Locations (10)

Advanced Foot Care

Phoenix, Arizona, United States

Keck Medicine of USC

Los Angeles, California, United States

Clemente Clinical Research

Santa Ana, California, United States

ILD Research Center

Vista, California, United States

Herco Medical Center

Flagami, Florida, United States

Gateway Clinical Trials

O'Fallon, Illinois, United States

OHSU

Portland, Oregon, United States

Futuro Clinical Trials

McAllen, Texas, United States

University of Texas Health Science Center

San Antonio, Texas, United States

Clinical Research Management Group

Mayagüez, Puerto Rico, Puerto Rico