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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
EDX110
DeviceEDX110 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
Treatment groups
298 Participants
are divided into 2 treatment groupsGroup A: EDX110 with Standard of Care (SOC)Active comparator 1 intervention
Group B: Standard of Care (SOC)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Wound Closure
Incidence of complete wound closure at 16 weeks in participants with DFU who are receiving standard of care (SOC) versus participants receiving EDX110 and SOC. Wound closure is defined as 100% reepithelialization of the wound without drainage.
Time frame
16 WeeksSecondary outcomes
1
Time to Wound Closure
Time to complete wound closure during treatment period in participants with DFU who are receiving standard of care (SOC) versus participants receiving EDX110 and SOC.
Time frame
16 Weeks2
Percent Area Reduction 4 weeks
The difference in the mean Percent Area of Reduction (PAR) at 4 weeks compared to baseline in participants with DFU who are receiving standard of care (SOC) versus participants receiving EDX110 and SOC.
Time frame
4 Weeks3
Percent Area Reduction 16 weeks
The difference in the mean Percent Area of Reduction (PAR) at 16 weeks compared to baseline in participants with DFU who are receiving standard of care (SOC) versus participants receiving EDX110 and SOC.
Time frame
16 weeks4
Wound closure at 24 weeks
Incidence of complete wound closure at 24 weeks in participants with DFU who are receiving standard of care (SOC) versus participants receiving EDX110 and SOC. Wound closure is defined as 100% reepithelialization of the wound without drainage.
Time frame
24 weeksOther outcomes
1
Hospitalizations relating to the target ulcer
Determine if the use of EDX110 leads to a reduction of the patient being hospitalized due to adverse events or complications related to their target ulcer.
Time frame
16 Weeks2
Amputations relating to the target ulcer
Determine if use of EDX110 leads to reduction in the occurrences of an amputation of the leg, foot, or toes due to the target ulcer.
Time frame
16 Weeks3
Systemic antibiotic usage during the 16-week treatment period
Determine if the use of EDX110 reduces the number of antibiotic treatments provided during the 16-week treatment period to the participant.
Time frame
16 Weeks4
Systemic antibiotic usage in the full 24-week study period
Determine if the use of EDX110 reduces the number of antibiotic treatments provided during the 24-week treatment period to the participant.
Time frame
24 WeeksSponsors and contacts
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Source ClinicalTrials.gov