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Recruiting

NCT Number: NCT05422248

Oxygen Wound Therapy Feasibility Study

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

Recruiting

Interested in participating?

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Key information

Conditions

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Otago Vascular Diagnostics

Dunedin, Otago, 9016, New Zealand

Location status: Recruiting

Location contact

Clinical Director

CONTACT

+64 3 474 0999

Clinical Nurse Specialist

CONTACT

+64 3 474 0999

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in wound area

    Time frame: 12 weeks

    cm^2

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Fisher and Paykel Healthcare

Industry

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jun 16, 2022
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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