Oxygen Wound Therapy Feasibility Study

NCT05422248 — Not applicable, Unknown, 10 participants, Fisher and Paykel Healthcare

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Registry	NCT05422248
Status	Unknown
Phase	Not applicable
Study type	Interventional; non randomized, parallel, masking: none, treatment
Enrollment	10 (Estimated)
Sponsor	Fisher and Paykel Healthcare (Industry)
Conditions	Chronic Leg Ulcer
Interventions	Series Topical Oxygen Therapy, Paired Topical Oxygen Therapy (Device)
Dates	start 2022-12-01, primary completion 2025-12-01 (estimated), completion 2026-08-01 (estimated), first posted 2022-06-16, last updated 2023-09-13
Locations	1 site in New Zealand

-Summary

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

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+Arms and interventions

Arm	Type	Interventions	Description
Series	Active comparator	Device: Series Topical Oxygen Therapy	Standard wound care for 4 weeks followed by intervention device wound care for up to 12 weeks.
Paired	Active comparator	Device: Paired Topical Oxygen Therapy	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.

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

+Outcome measures

Primary outcomes

Change in wound area [12 weeks]: cm\^2

+Eligibility

Sex: All, ages: 16 Years to any

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

+Locations (1)

Facility	City	Country	Status
Otago Vascular Diagnostics	Dunedin, Otago	New Zealand	Recruiting

+Investigators

Jolanta Krysa, Principal investigator, Southern DHB Vascular Surgery

My Notes

Public

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