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NCT Number: NCT05169814

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

The purpose of this study is to assess the safety and efficacy of Micro/nanobubbles (MNB's) for the healing of acute and chronic wounds.

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Key information

Conditions

Open Wound Wound Heal

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

About this study

Oxygen delivery is one of the primary factors in wound healing. Micro/nanobubbles (MNBs) can be used to increase the oxygen dissolved in solution and increase oxygen delivery to a wound. The purpose of this research study is to determine if MNBs applied to a wound improve wound healing.

After being informed about the study and potential risks, all patients will need to provide written informed consent before being included in the study. The characteristics of the wound will be assessed and measurements will be taken before and after treatment. Depending on the patient's wound type, the patient will be treated with MNBs in saline gauze which will be applied to the wound daily (for acute wounds), or MNBs in negative pressure wound therapy with instillation (NPWTi) (for chronic wounds) which will be applied to the wound continuously throughout the day with the wound evaluated and sponge replaced every 3-5 days. This is consistent with the current standard of wound care with gauze or NPWTi. Tissue oxygenation using infrared technology and wound healing will be measured and results collected for analysis.

Participation will last approximately 2-4 weeks or the duration of the inpatient admission. If discharge from the hospital is earlier than 2 weeks, the treatment will be discontinued and results will be submitted for analysis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Micro/nanobubble (MNB) - Irrigation

Drug

An MNB solution will be used as an irrigation solution to improve wound oxygenation in ischemic tissue (e.g. ischemic surgical tissue, traumatic wounds, and failing replants). The MNB solution will be used in wet-to-dry wound care dressings with daily scheduled dressing changes.

0.9% Normal Saline - Irrigation

Other

A normal saline solution will be used as an irrigation solution to improve wound oxygenation in ischemic tissue (e.g. ischemic surgical tissue, traumatic wounds, and failing replants). The normal saline solution will be used in wet-to-dry wound care dressings with daily scheduled dressing changes.

Micro/nanobubble (MNB) - Negative Pressure Wound Therapy with Instillation (NPWTi)

Drug

NPWTi with MNB will be applied to the wound with 20-minute instillation periods every 3 hours (standard instillation settings) with dressing changes every 3-5 days.

0.9% Normal Saline - Negative Pressure Wound Therapy with Instillation (NPWTi)

Other

NPWTi with normal saline will be applied to the wound with 20-minute instillation periods every 3 hours (standard instillation settings) with dressing changes every 3-5 days.

Primary outcomes

  1. Wound total oxygen saturation level

    Time frame: 2-4 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.

  2. Wound Size/ Surface Area (cm^2)

    Time frame: 2-4 weeks

    Daily photographs taken before initiation of treatment and during treatment.

  3. Analysis of wound pH

    Time frame: 2-4 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.

  4. Wound oxyhemoglobin concentration level

    Time frame: 2-4 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.

  5. Wound deoxyhemoglobin concentration level

    Time frame: 2-4 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.

  6. Analysis of wound GM-CSF concentration level

    Time frame: 2-4 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.

  7. Analysis of wound interferon concentration levels

    Time frame: 2-4 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.

  8. Analysis of wound interleukin (IL) concentration levels

    Time frame: 2-4 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.

  9. Analysis of wound tumor necrosis factor (TNF) concentration levels

    Time frame: 2-4 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.

  10. Analysis of wound Eotaxin (CCL11) concentration level

    Time frame: 2-4 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.

  11. Analysis of wound GRO alpha (CXCL1) concentration level

    Time frame: 2-4 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.

  12. Analysis of wound IP-10 (CXCL10) concentration level

    Time frame: 2-4 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.

  13. Analysis of wound MCP-1 (CCL2) concentration level

    Time frame: 2-4 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.

  14. Analysis of wound MIP-1 alpha (CCL3) concentration level

    Time frame: 2-4 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.

  15. Analysis of wound MIP-1 beta (CCL4) concentration level

    Time frame: 2-4 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.

  16. Analysis of wound RANTES (CCL5) concentration level

    Time frame: 2-4 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.

  17. Analysis of wound SDF-1 alpha concentration level

    Time frame: 2-4 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.

  18. Analysis of wound matrix metalloproteinase 1 (MMP1) concentration level

    Time frame: 2-4 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.

  19. Analysis of wound matrix metalloproteinase 8 (MMP8) concentration level

    Time frame: 2-4 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.

  20. Analysis of wound matrix metalloproteinase 13 (MMP13) concentration level

    Time frame: 2-4 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.

Secondary outcomes

  1. Hospital Length of Stay (LOS)

    Time frame: 2-4 weeks

    Days of hospital admission

  2. Number of participants that return to the operating room

    Time frame: 2-4 weeks

    Qualifying individuals include participants that return to the operating room for a procedure (e.g. surgical debridement) on the same wound being treated by the study investigators.

  3. Number of participants readmitted to the hospital for same wound after discharge

    Time frame: 4-8 weeks

    Qualifying individuals include participants that are readmitted to the hospital for the same wound that was treated by the study investigators.

Study contacts

Contact information is provided by the study sponsor or research team.

Leonardo Alaniz, BBA

CONTACT

[email protected]

602-318-7118

Lohrasb R Sayadi, MD

CONTACT

[email protected]

949-209-7267

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Official study title

Micro/Nanobubbles (MNBs) and Wound Therapy: A Pilot Study Involving a Novel Oxygen Delivery System for Treatment of Acute and Chronic Wounds

Acronym: MNB

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Dec 27, 2021
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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