Oxygen Wound Therapy Feasibility Study

Chronic Leg Ulcer Clinical Trial

Official title:

Oxygen Wound Therapy Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05422248
• Other study ID #: CIA-297
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: August 1, 2026

Study information

• Verified date: September 2023
• Source: Fisher and Paykel Healthcare
• Contact: Geoff Bold
• Phone: +64 (09) 574 0100
• Email: geoff.bold[@]fphcare.co.nz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: August 1, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Leg Ulcer
• Leg Ulcer

Intervention

Device:
• Series Topical Oxygen Therapy
Standard care provided to the whole wound followed by intervention device care to the whole wound.
• Paired Topical Oxygen Therapy
Care provided to one portion of wound by intervention device and standard care to remaining portion of wound.

Locations

Country	Name	City	State
New Zealand	Otago Vascular Diagnostics	Dunedin	Otago

Sponsors (1)

Lead Sponsor	Collaborator
Fisher and Paykel Healthcare

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in wound area	cm^2	12 weeks