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A Study on the Efficacy and Safety of a Nitric Oxide Generating Dressing in the Treatment of Diabetes Related Foot Ulcers.

ConditionDiabetic Foot Ulcers (DFUs)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorConvaTec Inc.

About this trial

Real world evidence study on the performance and safety of a nitric oxide generating dressing on the treatment of diabetic foot ulcers

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Palpable foot pulse with biphasic or triphasic pedal Doppler waveforms, AND

Ankle Brachial Index (ABI) >0.6 OR Toe Brachial Index (TBI) >0.5, OR

Toe pressure >40mmHg

Disqualifiers

None

Trial population

All subjects over the age of 18 years with a non-healing DFU (defined as failing to progress on a healing trajectory in the previous 4 weeks prior to enrolment) and treated with ConvaNiox (EDX110) will be screened for eligibility based on medical record review and discussions with the subject and their treating physician.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • ConvaNiox

    Device

    At each visit subjects will receive their Standard of Care (SoC) treatment for their DFU, but instead of their normal primary dressing they will receive an application of ConvaNiox (EDX110).

Treatment groups

102 Participants
are divided into 1 treatment group
Group A: Subjects with non-healing diabetes-related foot ulcers, treated with ConvaNiox1 intervention

Trial outcomes

Primary outcomes

1

Percentage area reduction

Time frame
at 12 weeks

Secondary outcomes

1

Incidence of wound closure

Time frame
at 12 weeks
2

Percentage area reduction

Time frame
at 4 weeks
3

Incidence of >50% percentage area reduction

Time frame
at 4 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ConvaTec Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: