Back to search results

Micro/Nanobubbles for Wound Healing

This study is testing if Micro/nanobubbles (MNBs) can help acute and chronic wounds heal better. MNBs are tiny bubbles that can increase oxygen in liquids, and oxygen is very important for wound healing. Researchers want to see if applying MNBs to wounds, either through daily wet-to-dry dressings or with a special wound therapy called Negative Pressure Wound Therapy with Instillation (NPWTi), improves healing compared to using normal saline. You might be able to join if you are over 18 and have various types of wounds, including traumatic, surgical, chronic, or burn injuries. The study will measure how much oxygen is in the wound, its size, and its pH level to see if the MNBs are effective. The study is currently unclear on its recruitment status and plans to enroll 40 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It will involve 40 participants, comparing MNBs to normal saline for wound care.
What's involved
You would receive daily wound care with MNBs or saline gauze for acute wounds, or continuous MNBs or saline with NPWTi for chronic wounds, with dressing changes every 3-5 days. Participation will last approximately 2-4 weeks or until hospital discharge.
Compensation
Not stated in the trial record.
Follow-up
Wound oxygen, size, and pH will be measured at 2-4 weeks, which indicates the follow-up period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05169814

Micro/Nanobubbles (MNBs) for Treatment of Acute and Chronic Wounds

Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatment
University of California, Irvine
~40 participants
Updated 2025-10-02 on ClinicalTrials.gov
What's tested:Micro/nanobubble (MNB) - Irrigation0.9% Normal Saline - IrrigationMicro/nanobubble (MNB) - Negative Pressure Wound Therapy with Instillation (NPWTi)0.9% Normal Saline - Negative Pressure Wound Therapy with Instillation (NPWTi)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Wound total oxygen saturation level
Measured over 2-4 weeks
+19 more outcomes measured

Conditions

Open Wound
Wound Heal

Explore related trials

BurnChronic woundDiabetic foot ulcerInjuryIschemic WoundNeuropathic ulcerPressure SoreRadiotherapy-induced Tissue InjuryStasis ulcerUlcer of artery

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Raj Vyas, MD · PRINCIPAL_INVESTIGATOR · University of California, Irvine, Dept. of Plastic Surgery; Vice-Chairman

Who to contact

Leonardo Alaniz, BBA
[email protected]
602-318-7118
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

have infected wounds.
have wounds with exposed vital structures such as nerves, arteries, and/or veins.
have wounds associated with malignancy.

What this trial measures

  • Wound total oxygen saturation level2-4 weeks

    Near Infrared Spectroscopy Imaging (NIRS) (KENT SnapShot https://www.kentimaging.com/product/) will be used to assess wound oxygenation saturation levels prior to the MNB or normal saline application. This will provide the investigators with a baseline oxygen saturation measurement. The NIRS KENT SnapShot is an FDA approved non-contact-based imaging modality used to assess wound/tissue oxygenation in the clinical setting and is currently available in the investigators' research laboratory.

  • Wound Size/ Surface Area (cm^2)2-4 weeks

    Daily photographs taken before initiation of treatment and during treatment.

  • Analysis of wound pH2-4 weeks

    With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups, and a pH strip will be used to measure the pH.

  • Wound oxyhemoglobin concentration level2-4 weeks

    Near Infrared Spectroscopy Imaging (NIRS) (KENT SnapShot https://www.kentimaging.com/product/) will be used to assess wound oxyhemoglobin concentration levels prior to the MNB or normal saline application. This will provide the investigators with a baseline oxygen tension measurement. The NIRS KENT SnapShot is an FDA approved non-contact-based imaging modality used to assess wound/tissue oxygenation in the clinical setting and is currently available in the investigators' research laboratory.

  • Wound deoxyhemoglobin concentration level2-4 weeks

    Near Infrared Spectroscopy Imaging (NIRS) (KENT SnapShot https://www.kentimaging.com/product/) will be used to assess wound deoxyhemoglobin concentration levels prior to the MNB or normal saline application. This will provide the investigators with a baseline oxygen tension measurement. The NIRS KENT SnapShot is an FDA approved non-contact-based imaging modality used to assess wound/tissue oxygenation in the clinical setting and is currently available in the investigators' research laboratory.

  • Analysis of wound GM-CSF concentration level2-4 weeks

    With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess GM-CSF concentration levels.

  • Analysis of wound interferon concentration levels2-4 weeks

    With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess the following interferon concentration levels: IFN alpha, IFN gamma. \*These levels will be reported in the same units of measure.

  • Analysis of wound interleukin (IL) concentration levels2-4 weeks

    With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess the following interleukin concentration levels: IL-1 alpha, IL-1 beta, IL-1RA, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8 (CXCL8), IL-9, IL-10, IL-12p70, IL-13, IL-15, IL-17A (CTLA-8), IL-18, IL-21, IL-22, IL-23, IL-27, IL-31. \*These levels will be reported in the same units of measure.

  • Analysis of wound tumor necrosis factor (TNF) concentration levels2-4 weeks

    With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess the following TNF concentration levels: TNF alpha, TNF beta. \*These levels will be reported in the same units of measure.

  • Analysis of wound Eotaxin (CCL11) concentration level2-4 weeks

    With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess Eotaxin (CCL11) concentration levels.

  • Analysis of wound GRO alpha (CXCL1) concentration level2-4 weeks

    With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess GRO alpha (CXCL1) concentration levels.

  • Analysis of wound IP-10 (CXCL10) concentration level2-4 weeks

    With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess IP-10 (CXCL10) concentration levels.

  • Analysis of wound MCP-1 (CCL2) concentration level2-4 weeks

    With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess MCP-1 (CCL2) concentration levels.

  • Analysis of wound MIP-1 alpha (CCL3) concentration level2-4 weeks

    With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess MIP-1 alpha (CCL3) concentration levels.

  • Analysis of wound MIP-1 beta (CCL4) concentration level2-4 weeks

    With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess MIP-1 beta (CCL4) concentration levels.

  • Analysis of wound RANTES (CCL5) concentration level2-4 weeks

    With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess RANTES (CCL5) concentration levels.

  • Analysis of wound SDF-1 alpha concentration level2-4 weeks

    With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess SDF-1 alpha concentration levels.

  • Analysis of wound matrix metalloproteinase 1 (MMP1) concentration level2-4 weeks

    With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess MMP1 concentration level.

  • Analysis of wound matrix metalloproteinase 8 (MMP8) concentration level2-4 weeks

    With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess MMP8 concentration level.

  • Analysis of wound matrix metalloproteinase 13 (MMP13) concentration level2-4 weeks

    With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess MMP 13 concentration level.