MNB Therapy for Wound Healing

(MNB Trial)

Overseen By Lohrasb R Sayadi, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of California, Irvine

Disqualifiers: Infected wounds, Exposed vital structures, Malignancy

Compensation: Varies

Number of Visits: Unknown

Duration: 2-4 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called micro/nanobubbles (MNBs) to determine if it aids in healing various types of wounds. Researchers aim to assess whether MNBs can safely and effectively treat both acute and chronic wounds. Some participants will receive standard treatments, while others will receive the MNB treatment. Individuals with wounds from surgery, burns, or ulcers might be suitable candidates for this trial. As an Early Phase 1 trial, participants will be among the first to receive this new treatment, assisting researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that tiny bubbles, called micro/nanobubbles (MNBs), have been studied for their ability to deliver oxygen to wounds, aiding in healing. Although this is a new area of research, early results suggest that MNBs are generally safe, with people usually not experiencing adverse reactions.

In studies on wound healing, major problems directly caused by MNBs have not been reported. So far, individuals using them for wound care have not faced significant issues. However, since this trial is in its early stages, researchers are still learning about all the safety aspects.

Because this is an early phase trial, the safety of the treatment for humans is still under investigation. Participants in early trials help researchers gather more detailed safety information. Those considering joining should discuss any questions or concerns with their healthcare provider. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about micro/nanobubble (MNB) therapy for wound healing because it offers a novel approach to treating acute and chronic wounds. Unlike standard care, which typically involves saline irrigation or negative pressure wound therapy, MNB therapy uses tiny gas-filled bubbles to enhance healing. These micro/nanobubbles can improve oxygen delivery and promote better blood flow to the wound site, potentially speeding up the healing process. This innovative method might lead to more effective and quicker recovery compared to traditional treatments, which is why it's generating a lot of interest.

What evidence suggests that micro/nanobubbles might be an effective treatment for wound healing?

Previous studies have shown that tiny bubbles called micro/nanobubbles (MNBs) can help wounds heal by delivering oxygen to damaged tissues. Research suggests these bubbles aid in healing both new and chronic wounds by improving the oxygen supply, essential for tissue repair. In this trial, participants with acute wounds will be divided into separate arms: one group will receive standard care with normal saline, and another will receive the experimental treatment with MNBs in normal saline. Similarly, for chronic wounds, one arm will receive standard care with normal saline, while another will receive the experimental MNB treatment. Although more research is needed, these early findings offer hope for those with hard-to-heal wounds. ^{1 2 4 6 7}

Who Is on the Research Team?

Raj Vyas, MD

Principal Investigator

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

Are You a Good Fit for This Trial?

This trial is for adults over 18 with various types of wounds, including traumatic, surgical, chronic wounds, pressure ulcers (like diabetic foot or venous ulcers), radiotherapy tissue injury, and burns. It's not for those with infected wounds, exposed vital structures like nerves or arteries in the wound area, or cancer-related wounds.

Inclusion Criteria

I have wounds from an injury, surgery, or a long-term condition.

I have fresh wounds caused by poor blood flow.

I have injuries from burns (heat, chemicals, or electricity).

Exclusion Criteria

I have wounds caused by cancer.

I have wounds that expose important body parts like nerves or blood vessels.

I have an infected wound.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive either standard care or experimental treatment with micro/nanobubbles (MNBs) for wound healing

2-4 weeks

Daily treatment applications

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 0.9% Normal Saline
• Micro/nanobubble (MNB)

Trial Overview The study tests if Micro/nanobubbles (MNBs) can help heal acute and chronic wounds better than normal saline. Participants will receive either MNB irrigation alone or combined with Negative Pressure Wound Therapy compared to saline treatments.

How Is the Trial Designed?

Group I: Chronic Wounds - Experimental Experimental Treatment 1 Intervention

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.

Group II: Acute Wounds - Experimental Experimental Treatment 1 Intervention

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

Group III: Acute Wounds - Control Placebo Group 1 Intervention

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

Group IV: Chronic Wounds - Control Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

Published Research Related to This Trial

Micro/nanobubbles (MNBs) are promising for applications in angiography and drug delivery due to their unique structure and ability to act as contrast agents.

The review emphasizes the importance of understanding the stability of MNBs, particularly under ultrasonic conditions, as this stability directly impacts their effectiveness in medical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stability of Engineered Micro or Nanobubbles for Biomedical Applications. Park, B., Yoon, S., Choi, Y., et al.[2020]

Microbubbles and nanobubbles (MNBs) offer a promising alternative to traditional radiologic methods and medication administration, potentially reducing side effects while providing diagnostic and therapeutic benefits.

MNBs have diverse applications, including ultrasound imaging, chronic treatments for conditions like osteoporosis and cancer, and acute treatments for infections, indicating their versatility in various medical fields.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bubble-Based Drug Delivery Systems: Next-Generation Diagnosis to Therapy. Kancheva, M., Aronson, L., Pattilachan, T., et al.[2023]

Microbubbles and nanobubbles (MNBs) can be engineered to improve drug and oxygen delivery in tumors, particularly in hypoxic areas that are resistant to conventional therapies.

MNBs not only enhance the accumulation of therapeutic agents but also help reverse hypoxic conditions in tumors, potentially increasing the effectiveness of treatments like photodynamic therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oxygen-Carrying Micro/Nanobubbles: Composition, Synthesis Techniques and Potential Prospects in Photo-Triggered Theranostics. Khan, MS., Hwang, J., Lee, K., et al.[2023]

Nanobubbles (NBs) containing oxygen are emerging as a promising alternative to traditional ventilator systems for treating hypoxic patients, particularly those affected by COVID-19, by improving tissue oxygenation and supporting respiratory function.

Oxygen-carrying NBs not only enhance oxygen delivery but also possess additional benefits such as anti-inflammatory and antibacterial properties, making them a multifunctional treatment option for acute hypoxemic respiratory failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of Oxygenation with Nanobubbles: Possible Treatment for Hypoxic COVID-19 Patients. Afshari, R., Akhavan, O., Hamblin, MR., et al.[2023]

Magnetic Oxygen-Loaded Nanobubbles (MOLNBs) are safe and effective carriers for delivering oxygen and chemotherapy to brain tumors, capable of crossing the blood-brain barrier and being directed to specific sites using magnetic fields.

MOLNBs can be monitored using Magnetic Resonance Imaging (MRI) or Ultrasound (US), making them valuable for enhancing conventional treatments like radiotherapy while providing targeted drug delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beyond Oncological Hyperthermia: Physically Drivable Magnetic Nanobubbles as Novel Multipurpose Theranostic Carriers in the Central Nervous System. Ficiarà, E., Ansari, SA., Argenziano, M., et al.[2021]

In a study involving 12 rats with acute lung injury, the administration of oxygen nanobubbles (ONBs) did not show any significant improvement in arterial oxygen levels or mean arterial pressure compared to the control group.

The levels of inflammatory cytokines TNF-α and IL-6 were also similar between the ONB and control groups, indicating that the ONB treatment did not have an anti-inflammatory effect at the tested dose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigation of anti-inflammatory effects of oxygen nanobubbles in a rat hydrochloric acid lung injury model. Yoshida, K., Ikegami, Y., Obara, S., et al.[2021]

Nitrogen nanobubbles (N-NBs) were shown to increase the number of fibroblast cells by 11% in culture, indicating a potential for promoting cell proliferation.

However, further analysis revealed that N-NBs did not significantly affect cell division, suggesting that more research is needed to understand their role in other cellular processes like apoptosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proliferative effects of nanobubbles on fibroblasts. Heo, H., Park, J., Lee, JI., et al.[2022]

Air-nanobubble water significantly enhanced the growth of Brassica campestris, leading to taller plants and greater fresh weight compared to normal water, indicating its potential as a growth stimulant in hydroponics.

Both air-nanobubble water and oxygen-nanobubble water improved the weight gain and growth of sweetfish, rainbow trout, and mice, suggesting that nanobubble technology could be an effective tool for promoting growth in various living organisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oxygen and air nanobubble water solution promote the growth of plants, fishes, and mice. Ebina, K., Shi, K., Hirao, M., et al.[2021]

Oxygen nanobubbles (OnB) represent a promising new method for delivering oxygen to cells, which could help treat hypoxia-related conditions like cancer and COVID-19 by improving mitochondrial function and cellular metabolism.

The review highlights various OnB delivery strategies, such as diffusion and ultrasound, and their potential to activate hypoxia-induced factors (HiFs), suggesting that OnB could play a significant role in developing therapies for chronic diseases linked to low oxygen levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NanoBubble-Mediated Oxygenation: Elucidating the Underlying Molecular Mechanisms in Hypoxia and Mitochondrial-Related Pathologies. Viafara Garcia, SM., Khan, MS., Haidar, ZS., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8555472/

A Quantitative Assessment of Wound Healing with ... Oxygen carrying Micro/nanobubbles, (MNB(O2)), offer a novel technology which can be used to effectively deliver oxygen to burn wounds and potentially counteract ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05169814

Micro/​Nanobubbles (MNBs) for Treatment of Acute and ... 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. Detailed Description.

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05169814/micro-nanobubbles-mnbs-for-treatment-of-acute-and-chronic-wounds

Micro/Nanobubbles (MNBs) for Treatment of Acute and ... 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.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7950116/

Topical oxygen therapy & micro/nanobubbles The aim of this article is to systematically review literature examining the use of TOT for wound healing and use of MNBs for tissue oxygenation ...

5. researchgate.net researchgate.net/publication/355000538_A_Quantitative_Assessment_of_Wound_Healing_With_Oxygenated_MicroNanobubbles_in_a_Preclinical_Burn_Model

(PDF) A Quantitative Assessment of Wound Healing With ... 2006;5:e2). Oxygen-carrying micro/nanobubbles, MNB(O2), offer a novel technology that can be used to effectively deliver oxygen to burn wounds ...

6. ctv.veeva.com ctv.veeva.com/study/micro-nanobubbles-mnbs-for-treatment-of-acute-and-chronic-wounds

Micro/Nanobubbles (MNBs) for Treatment of Acute and ... 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.

7. clinconnect.io clinconnect.io/trials/NCT05169814

Micro/Nanobubbles (MNBs) for Treatment of Acute and 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.