Using oxygen therapy to treat chronic leg ulcers
Oxygen Wound Therapy Feasibility Study
This study is testing a new oxygen therapy device to see if it can help heal stubborn leg ulcers in people aged 16 and older.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Fisher and Paykel Healthcare Industry-sponsored |
| Locations | 1 site (Dunedin, Otago) |
| Trial ID | NCT05422248 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the feasibility of a new topical oxygen therapy device designed for treating hard-to-heal lower leg wounds. Participants will receive either series or paired topical oxygen therapy to evaluate the effectiveness of this innovative approach. The study will include patients aged 16 and over with specific inclusion criteria related to their wound characteristics. The goal is to gather preliminary data on the therapy's potential benefits for chronic leg ulcer treatment.
Who should consider this trial
Good fit: Ideal candidates are patients aged 16 and over with hard-to-heal lower leg wounds as determined by their clinician.
Not a fit: Patients with infected wounds requiring antibiotics or those with exposed bone or tendon will not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve healing rates for patients with chronic leg ulcers.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, indicating that this may be a novel exploration in the field.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Dunedin, Otago
- Otago Vascular Diagnostics — Dunedin, Otago, New Zealand (Recruiting)
Study contacts
- Principal investigator: Jolanta Krysa — Southern DHB Vascular Surgery
- Study coordinator: Geoff Bold
- Email: geoff.bold@fphcare.co.nz
- Phone: +64 (09) 574 0100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.