Status:
RECRUITING
Oxygen Wound Therapy Feasibility Study
Lead Sponsor:
Fisher and Paykel Healthcare
Conditions:
Chronic Leg Ulcer
Eligibility:
All Genders
16+ years
Phase:
NA
Brief Summary
Determine the feasibility of using a new topical oxygen therapy device to treat hard to heal lower leg wounds.
Eligibility Criteria
Inclusion
- Patients with hard to heal lower leg wounds as determined by the treating clinician.
- Patient has a wound area greater than the area of the interface
- Aged 16 years and over
- Able to provide informed consent
Exclusion
- Lower limb wounds with bone or tendon exposed
- Infected wounds which require treatment with antibiotics
- Wounds with critical bioburden requiring a medicated dressing
- Wounds that require dressing changes more than every second day, for example high exudating wounds
- Wounds with slough covering more than 30% of the wound surface
Key Trial Info
Start Date :
December 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05422248
Start Date
December 1 2022
End Date
August 1 2026
Last Update
September 13 2023
Active Locations (1)
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1
Otago Vascular Diagnostics
Dunedin, Otago, New Zealand, 9016