Oxygen Wound Therapy Feasibility Study

Last updated: September 11, 2023
Sponsor: Fisher and Paykel Healthcare
Overall Status: Active - Recruiting

Phase

N/A

Condition

Venous Leg Ulcers

Ulcers

Treatment

Paired Topical Oxygen Therapy

Series Topical Oxygen Therapy

Clinical Study ID

NCT05422248
CIA-297
  • Ages > 16
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

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 highexudating wounds
  • Wounds with slough covering more than 30% of the wound surface

Study Design

Total Participants: 10
Treatment Group(s): 2
Primary Treatment: Paired Topical Oxygen Therapy
Phase:
Study Start date:
December 01, 2022
Estimated Completion Date:
August 01, 2026

Connect with a study center

  • Otago Vascular Diagnostics

    Dunedin, Otago 9016
    New Zealand

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.