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Oxygen Wound Therapy Feasibility Study

Primary Purpose

Chronic Leg Ulcer

Status

Recruiting

Phase

Not Applicable

Locations

New Zealand

Study Type

Interventional

Intervention

Series Topical Oxygen Therapy

Paired Topical Oxygen Therapy

About this trial

This is an interventional treatment trial for Chronic Leg Ulcer

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Otago Vascular DiagnosticsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Series

Paired

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Change in wound area

cm^2

Secondary Outcome Measures

Full Information

NCT ID

NCT05422248

First Posted

June 13, 2022

Last Updated

September 11, 2023

Sponsor

Fisher and Paykel Healthcare

1. Study Identification

Unique Protocol Identification Number

NCT05422248

Brief Title

Oxygen Wound Therapy Feasibility Study

Official Title

Oxygen Wound Therapy Feasibility Study

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 1, 2022 (Actual)

Primary Completion Date

December 1, 2025 (Anticipated)

Study Completion Date

August 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fisher and Paykel Healthcare

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Leg Ulcer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Series

Arm Type

Active Comparator

Arm Description

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

Arm Title

Paired

Arm Type

Active Comparator

Arm 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.

Intervention Type

Device

Intervention Name(s)

Series Topical Oxygen Therapy

Intervention Description

Standard care provided to the whole wound followed by intervention device care to the whole wound.

Intervention Type

Device

Intervention Name(s)

Paired Topical Oxygen Therapy

Intervention Description

Care provided to one portion of wound by intervention device and standard care to remaining portion of wound.

Primary Outcome Measure Information:

Title

Change in wound area

Description

cm^2

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Geoff Bold

Phone

+64 (09) 574 0100

geoff.bold@fphcare.co.nz

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jolanta Krysa

Organizational Affiliation

Southern DHB Vascular Surgery

Official's Role

Principal Investigator

Facility Information:

Facility Name

Otago Vascular Diagnostics

City

Dunedin

State/Province

Otago

ZIP/Postal Code

9016

Country

New Zealand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Clinical Director

Phone

+64 3 474 0999

First Name & Middle Initial & Last Name & Degree

Clinical Nurse Specialist

Phone

+64 3 474 0999

12. IPD Sharing Statement

Learn more about this trial

Oxygen Wound Therapy Feasibility Study

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