Oxygen Wound Therapy Feasibility Study

Sponsor
Fisher and Paykel Healthcare (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05422248
Collaborator
(none)
10
2
12

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Series Topical Oxygen Therapy
  • Device: Paired Topical Oxygen Therapy
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Oxygen Wound Therapy Feasibility Study
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in wound area [12 weeks]

    cm^2

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Fisher and Paykel Healthcare

Investigators

  • Principal Investigator: Jolanta Krysa, Southern DHB Vascular Surgery

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fisher and Paykel Healthcare
ClinicalTrials.gov Identifier:
NCT05422248
Other Study ID Numbers:
  • CIA-297
First Posted:
Jun 16, 2022
Last Update Posted:
Jun 22, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 22, 2022