Oxygen Wound Therapy Feasibility Study

Not Applicable

Recruiting

• Conditions: Chronic Leg Ulcer

• Registration Number: NCT05422248
• Lead Sponsor: Fisher and Paykel Healthcare

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-13
• Study First Submitted QC: 2022-06-13
• Study First Posted: 2022-06-16
• Study Start: 2022-12-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-11
• Last Update Posted: 2023-09-13
• Primary Completion: 2025-12-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in wound area	12 weeks	cm\^2

Trial Locations

Locations (1)

Otago Vascular Diagnostics; 🇳🇿 Dunedin, Otago, New Zealand