Oxygen Wound Therapy Feasibility Study
ConditionChronic Leg Ulcer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorFisher and Paykel Healthcare
About this trial
Determine the feasibility of using a new topical oxygen therapy device to treat hard to heal lower leg wounds.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Series Topical Oxygen Therapy
DeviceStandard care provided to the whole wound followed by intervention device care to the whole wound.
Paired Topical Oxygen Therapy
DeviceCare provided to one portion of wound by intervention device and standard care to remaining portion of wound.
Treatment groups
10 Participants
are divided into 2 treatment groupsGroup A: SeriesActive comparator 1 intervention
Group B: PairedActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in wound area
cm\^2
Time frame
12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov