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

NCT05169814 | Recruiting Early Phase 1 DMC FDA Drug

• 2 other identifiers: 5901154138
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (20)

• Wound total oxygen saturation level

  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.

  2-4 weeks

• Wound Size/ Surface Area (cm^2)

  Daily photographs taken before initiation of treatment and during treatment.

  2-4 weeks

• Analysis of wound pH

  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.

  2-4 weeks

• Wound oxyhemoglobin concentration level

  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.

  2-4 weeks

• Wound deoxyhemoglobin concentration level

  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.

  2-4 weeks

• Analysis of wound GM-CSF concentration level

  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.

  2-4 weeks

• Analysis of wound interferon concentration levels

  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.

  2-4 weeks

• Analysis of wound interleukin (IL) concentration levels

  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.

  2-4 weeks

• Analysis of wound tumor necrosis factor (TNF) concentration levels

  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.

  2-4 weeks

• Analysis of wound Eotaxin (CCL11) concentration level

  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.

  2-4 weeks

• Analysis of wound GRO alpha (CXCL1) concentration level

  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.

  2-4 weeks

• Analysis of wound IP-10 (CXCL10) concentration level

  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.

  2-4 weeks

• Analysis of wound MCP-1 (CCL2) concentration level

  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.

  2-4 weeks

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

  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.

  2-4 weeks

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

  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.

  2-4 weeks

• Analysis of wound RANTES (CCL5) concentration level

  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.

  2-4 weeks

• Analysis of wound SDF-1 alpha concentration level

  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.

  2-4 weeks

• Analysis of wound matrix metalloproteinase 1 (MMP1) concentration level

  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.

  2-4 weeks

• Analysis of wound matrix metalloproteinase 8 (MMP8) concentration level

  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.

  2-4 weeks

• Analysis of wound matrix metalloproteinase 13 (MMP13) concentration level

  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.

  2-4 weeks

Secondary Outcomes (3)

• Hospital Length of Stay (LOS)

  2-4 weeks

• Number of participants that return to the operating room

  2-4 weeks

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

  4-8 weeks

Study Arms (4)

Acute Wounds - Control

PLACEBO COMPARATOR

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

Other: 0.9% Normal Saline - Irrigation

Acute Wounds - Experimental

EXPERIMENTAL

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

Drug: Micro/nanobubble (MNB) - Irrigation

Chronic Wounds - Control

PLACEBO COMPARATOR

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

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

Chronic Wounds - Experimental

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.

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

Interventions

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.

Acute Wounds - Experimental

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.

Acute Wounds - Control

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.

Chronic Wounds - Experimental

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.

Chronic Wounds - Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

UCI Medical Center

Orange, California, 92868, United States

RECRUITING

Related Publications (7)

• Tsuge H. Micro- and Nanobubbles: Fundamentals and Applications. Boca Raton: CRC Press; 2014.

  BACKGROUND

• Matiasek J, Djedovic G, Kiehlmann M, Verstappen R, Rieger UM. Negative pressure wound therapy with instillation: effects on healing of category 4 pressure ulcers. Plastic and Aesthetic Research. 2018;5.

  BACKGROUND

• Sayadi LR, Banyard DA, Ziegler ME, Obagi Z, Prussak J, Klopfer MJ, Evans GR, Widgerow AD. Topical oxygen therapy & micro/nanobubbles: a new modality for tissue oxygen delivery. Int Wound J. 2018 Jun;15(3):363-374. doi: 10.1111/iwj.12873. Epub 2018 Jan 5.

  PMID: 29314626 RESULT

• Khan MS, Hwang J, Lee K, Choi Y, Kim K, Koo HJ, Hong JW, Choi J. Oxygen-Carrying Micro/Nanobubbles: Composition, Synthesis Techniques and Potential Prospects in Photo-Triggered Theranostics. Molecules. 2018 Aug 31;23(9):2210. doi: 10.3390/molecules23092210.

  PMID: 30200336 RESULT

• Lalezari S, Lee CJ, Borovikova AA, Banyard DA, Paydar KZ, Wirth GA, Widgerow AD. Deconstructing negative pressure wound therapy. Int Wound J. 2017 Aug;14(4):649-657. doi: 10.1111/iwj.12658. Epub 2016 Sep 29.

  PMID: 27681204 RESULT

• Back DA, Scheuermann-Poley C, Willy C. Recommendations on negative pressure wound therapy with instillation and antimicrobial solutions - when, where and how to use: what does the evidence show? Int Wound J. 2013 Dec;10 Suppl 1(Suppl 1):32-42. doi: 10.1111/iwj.12183.

  PMID: 24251842 RESULT

• Jarbrink K, Ni G, Sonnergren H, Schmidtchen A, Pang C, Bajpai R, Car J. The humanistic and economic burden of chronic wounds: a protocol for a systematic review. Syst Rev. 2017 Jan 24;6(1):15. doi: 10.1186/s13643-016-0400-8.

  PMID: 28118847 RESULT

MeSH Terms

Interventions

Therapeutic Irrigation; Negative-Pressure Wound Therapy

Intervention Hierarchy (Ancestors)

Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation; Investigative Techniques; Drainage; Surgical Procedures, Operative; Wound Closure Techniques

Study Officials

• Raj Vyas, MD

  University of California, Irvine, Dept. of Plastic Surgery; Vice-Chairman

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leonardo Alaniz, BBA

CONTACT

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

Lohrasb R Sayadi, MD

CONTACT

949-209-7267; rsayadi@uci.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind, controlled study. Participants will be selected and matched based on similar wound profiles, pathology mechanisms, comorbidity profiles, and age. They will randomly be assigned to the experimental (MNB) or control (normal saline) group. The randomization ratio between both groups will be 1:1. Measurements of objective datapoints (e.g. StO2), cytokines, proteases, and pH will be taken by blinded research personnel.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lead Investigator

Model Details: This is a pilot study that consists of 4 arms: * Acute wounds: 1 control arm; 1 experimental arm (treated with MNB irrigation) * Chronic wounds: 1 control arm; 1 experimental arm (treated with Negative pressure wound therapy with MNB instillation)

Study Record Dates

• First Submitted: November 4, 2021
• First Posted: December 27, 2021
• Study Start: October 9, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: October 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)