Using micro/nanobubbles to heal acute and chronic wounds
Micro/Nanobubbles (MNBs) and Wound Therapy: A Pilot Study Involving a Novel Oxygen Delivery System for Treatment of Acute and Chronic Wounds
This study is testing if tiny bubbles can help heal both new and long-lasting wounds by improving oxygen delivery to the affected areas.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, Irvine Academic / other |
| Locations | 1 site (Orange, California) |
| Trial ID | NCT05169814 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of micro/nanobubbles (MNBs) in promoting the healing of acute and chronic wounds. By enhancing oxygen delivery to the wound site, MNBs may improve healing outcomes. Participants will receive MNB treatment either through saline gauze for acute wounds or negative pressure wound therapy with instillation for chronic wounds. Wound characteristics will be assessed before and after treatment, with measurements taken to analyze the impact of MNBs on healing.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with traumatic, surgical, or chronic wounds, as well as specific types of ulcers and burn injuries.
Not a fit: Patients with infected wounds or those with wounds involving vital structures or malignancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly enhance wound healing for patients with various types of wounds.
How similar studies have performed: While the use of MNBs is a novel approach, similar studies have shown promise in enhancing oxygen delivery for wound healing.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * are above the age of 18. * have traumatic, surgical, or chronic wounds. * have radiotherapy related tissue injury. * have thermal, chemical, and/or electrical burn injuries. * have pressure ulcers, diabetic foot ulcers, venous ulcers, arterial ulcers, and/or neuropathic skin ulcers. * have acute ischemic wounds Exclusion Criteria: * have infected wounds. * have wounds with exposed vital structures such as nerves, arteries, and/or veins. * have wounds associated with malignancy.
Where this trial is running
Orange, California
- UCI Medical Center — Orange, California, United States (Recruiting)
Study contacts
- Principal investigator: Raj Vyas, MD — University of California, Irvine, Dept. of Plastic Surgery; Vice-Chairman
- Study coordinator: Leonardo Alaniz, BBA
- Email: alanizl1@hs.uci.edu
- Phone: 602-318-7118
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.