Chronic Leg Ulcer
Conditions
Brief summary
Determine the feasibility of using a new topical oxygen therapy device to treat hard to heal lower leg wounds.
Interventions
DEVICESeries Topical Oxygen Therapy
Standard care provided to the whole wound followed by intervention device care to the whole wound.
DEVICEPaired Topical Oxygen Therapy
Care provided to one portion of wound by intervention device and standard care to remaining portion of wound.
Sponsors
Fisher and Paykel Healthcare
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in wound area | 12 weeks | cm\^2 |
Countries
New Zealand
Contacts
Primary ContactGeoff Bold
Outcome results
None listed