EDX110 Randomized Control Trial for Treatment of DFUs
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorConvaTec Inc.
About this trial
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.
Eligibility criteria
Qualifiers
Participants at least 18 years old and willing to participate in all procedures and follow-up evaluations necessary to complete the study.
Non-healing DFU defined as; at least 4 weeks prior to enrolment the ulcer has failed to progress on a healing trajectory.
Full-thickness wound; defined as Wagner Diabetic Foot Ulcer Grade 1 - superficial ulcer of skin or subcutaneous tissue.
Located on the anatomical foot; defined as distal to the medial or lateral malleolus.
Disqualifiers
Wagner Grade 2 - ulcers extend into tendon, bone, or capsule
Grade 3 - deep ulcer with osteomyelitis, or abscess
Grade 4 - partial foot gangrene
Grade 5 - whole foot gangrene
Trial design
Treatments tested in this trial
- EDX110
Treatment groups
298 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov