Oxygen Wound Therapy Feasibility Study

Fisher & Paykel Healthcare

Status: Enrolling

Conditions: Chronic Leg Ulcer

Treatments: Device: Paired Topical Oxygen Therapy; Device: Series Topical Oxygen Therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT05422248

CIA-297

Details and patient eligibility

About

Determine the feasibility of using a new topical oxygen therapy device to treat hard to heal lower leg wounds.

Enrollment: 10 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Series

Active Comparator group

Description:

Standard wound care for 4 weeks followed by intervention device wound care for up to 12 weeks.

Treatment:

Device: Series Topical Oxygen Therapy

Paired

Active Comparator group

Description:

Intervention device wound care to a portion of wound and standard wound care to the remaining portion of the wound, for up to 12 weeks.

Treatment:

Device: Paired Topical Oxygen Therapy