NCT05422248

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started Dec 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Dec 2022Aug 2026

First Submitted

Initial submission to the registry

June 13, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 16, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Expected
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

3 years

First QC Date

June 13, 2022

Last Update Submit

September 11, 2023

Conditions

Chronic Leg Ulcer

Outcome Measures

Primary Outcomes (1)

  • Change in wound area

    cm\^2

    12 weeks

Study Arms (2)

Series

ACTIVE COMPARATOR

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

Device: Series Topical Oxygen Therapy

Paired

ACTIVE COMPARATOR

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

Interventions

Series Topical Oxygen TherapyDEVICE

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

Series
Paired Topical Oxygen TherapyDEVICE

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

Paired

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Otago Vascular Diagnostics

Dunedin, Otago, 9016, New Zealand

RECRUITING

Study Officials

  • Jolanta Krysa

    Southern DHB Vascular Surgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Geoff Bold

CONTACT

+64 (09) 574 0100geoff.bold@fphcare.co.nz

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2022

First Posted

June 16, 2022

Study Start

December 1, 2022

Primary Completion

December 1, 2025

Study Completion (Estimated)

August 1, 2026

Last Updated

September 13, 2023

Record last verified: 2023-09

Locations

NZ(1)