Oxygen Wound Therapy Feasibility Study | NCT05422248

Studies
Oxygen Wound Therapy Feasibility Study

NCT05422248

Sponsor

Fisher and Paykel Healthcare

Status

Recruiting

Last Update Posted

Sep 13, 2023Actual

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Chronic Leg Ulcer

Interventions

Series Topical Oxygen Therapy
Paired Topical Oxygen Therapy

Countries

New Zealand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2022Actual

Primary Completion Date

Dec 1, 2025Estimated

Completion Date

Aug 1, 2026Estimated

First Submitted Date

Jun 13, 2022

First Submission Date that Met QC Criteria

Jun 13, 2022

First Posted Date

Jun 16, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 11, 2023

Last Update Posted Date

Sep 13, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Series	Active Comparator	Standard wound care for 4 weeks followed by intervention device wound care for up to 12 weeks.	Device: Series Topical Oxygen Therapy
Paired	Active Comparator	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.	Device: Paired Topical Oxygen Therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Series Topical Oxygen Therapy	Device	Standard care provided to the whole wound followed by intervention device care to the whole wound.	Series

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in wound area	cm^2	12 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Geoff Bold	Contact	+64 (09) 574 0100		geoff.bold@fphcare.co.nz

Overall Officials

Name	Affiliation	Role
Jolanta Krysa	Southern DHB Vascular Surgery	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Otago Vascular Diagnostics	Recruiting	Dunedin	Otago	9016	New Zealand