Recruiting

Early Phase 1

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

Sponsor:

UCLA

Code:

NCT05169814

Conditions

Open Wound

Wound Heal

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Micro/nanobubble (MNB) - Irrigation

0.9% Normal Saline - Irrigation

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

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

Study Details

Brief summary:

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.

Conditions

Open Wound

Wound Heal

Study ID

NCT05169814

Start date

Oct 9, 2021

Status verified date

Jun, 2025

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Jun 1, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Acute Wounds - Control

This arm will include patients with acute wounds and will receive standard of care: irrigation with normal saline.

experimental: Acute Wounds - Experimental

This arm will include patients with acute wounds and will receive experimental treatment: irrigation with micro/nanobubbles (MNB's) in normal saline.

placebo comparator: Chronic Wounds - Control

This arm will include patients with chronic wounds and will receive standard of care: negative pressure wound therapy with instillation (NPWTi) using normal saline.

experimental: Chronic Wounds - Experimental

This arm will include patients with chronic wounds and will receive experimental treatment: negative pressure wound therapy with instillation (NPWTi) using micro/nanobubbles (MNB's) in normal saline.

Interventions

Micro/nanobubble (MNB) - Irrigation

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

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)

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)

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 outcome measure

Wound total oxygen saturation level [ Time Frame: 2-4 weeks ]
Wound Size/ Surface Area (cm^2) [ Time Frame: 2-4 weeks ]
Analysis of wound pH [ Time Frame: 2-4 weeks ]
Wound oxyhemoglobin concentration level [ Time Frame: 2-4 weeks ]
Wound deoxyhemoglobin concentration level [ Time Frame: 2-4 weeks ]
Analysis of wound GM-CSF concentration level [ Time Frame: 2-4 weeks ]
Analysis of wound interferon concentration levels [ Time Frame: 2-4 weeks ]
Analysis of wound interleukin (IL) concentration levels [ Time Frame: 2-4 weeks ]
Analysis of wound tumor necrosis factor (TNF) concentration levels [ Time Frame: 2-4 weeks ]
Analysis of wound Eotaxin (CCL11) concentration level [ Time Frame: 2-4 weeks ]
Analysis of wound GRO alpha (CXCL1) concentration level [ Time Frame: 2-4 weeks ]
Analysis of wound IP-10 (CXCL10) concentration level [ Time Frame: 2-4 weeks ]
Analysis of wound MCP-1 (CCL2) concentration level [ Time Frame: 2-4 weeks ]
Analysis of wound MIP-1 alpha (CCL3) concentration level [ Time Frame: 2-4 weeks ]
Analysis of wound MIP-1 beta (CCL4) concentration level [ Time Frame: 2-4 weeks ]
Analysis of wound RANTES (CCL5) concentration level [ Time Frame: 2-4 weeks ]
Analysis of wound SDF-1 alpha concentration level [ Time Frame: 2-4 weeks ]
Analysis of wound matrix metalloproteinase 1 (MMP1) concentration level [ Time Frame: 2-4 weeks ]
Analysis of wound matrix metalloproteinase 8 (MMP8) concentration level [ Time Frame: 2-4 weeks ]
Analysis of wound matrix metalloproteinase 13 (MMP13) concentration level [ Time Frame: 2-4 weeks ]

Central Contacts and Locations

Central contacts

Leonardo Alaniz, BBA

602-318-7118 alanizl1@hs.uci.edu

Lohrasb R Sayadi, MD

949-209-7267 rsayadi@uci.edu

Locations

UCI Medical Center

Recruiting

Orange, California, United States, 92868

Contacts

Leonardo Alaniz, MD

602-318-7118 alanizl1@hs.uci.edu

Lohrasb R Sayadi, MD

(949) 209-7267 rsayadi@uci.edu

More Information

Sponsor

University of California, Irvine

Last update posted

Oct 2, 2025

Last verified

Jun, 2025

Keywords

acute wounds
chronic wounds
MNB solution
MNB
Micro/nanobubbles
Micronanobubbles
negative pressure wound therapy with instillation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Irvine on 2025-10-02.