Oxygen Wound Therapy Feasibility Study

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

Study Overview

• Status: Recruiting
• Conditions: Chronic Leg Ulcer
• Intervention / Treatment: Device: Series Topical Oxygen Therapy; Device: Paired Topical Oxygen Therapy

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Geoff Bold; Phone Number: +64 (09) 574 0100; Email: geoff.bold@fphcare.co.nz

Study Locations

• New Zealand
  • Otago
    • Dunedin, Otago, New Zealand, 9016
      • Recruiting
      • Otago Vascular Diagnostics
      • Contact: Clinical Director; Phone Number: +64 3 474 0999
      • Contact: Clinical Nurse Specialist; Phone Number: +64 3 474 0999

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Series; Standard wound care for 4 weeks followed by intervention device wound care for up to 12 weeks.	Device: Series Topical Oxygen Therapy; Standard care provided to the whole wound followed by intervention device care to the whole wound.
Active Comparator: Paired; 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; Care provided to one portion of wound by intervention device and standard care to remaining portion of wound.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fisher and Paykel Healthcare
• Investigators: Principal Investigator: Jolanta Krysa, Southern DHB Vascular Surgery

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: June 13, 2022
• First Submitted That Met QC Criteria: June 13, 2022
• First Posted (Actual): June 16, 2022

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Leg Ulcer
• Other Study ID Numbers: CIA-297

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No