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

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the MNB therapy for wound healing?

Research shows that micro/nanobubbles (MNBs) can deliver oxygen effectively, which may help improve conditions where oxygen is lacking, such as in wound healing. MNBs have been used in other medical applications to enhance oxygen levels in tissues, potentially aiding in faster recovery and healing. ^{1 2 3 4 5}

Is MNB therapy generally safe for humans?

Research on micro/nanobubbles (MNBs) suggests they are being explored for various medical uses, including drug delivery and imaging, without significant safety concerns reported. Studies in animals and cell cultures have not shown harmful effects, but more research is needed to confirm safety in humans. ^{1 2 3 6 7}

How is MNB therapy for wound healing different from other treatments?

MNB therapy is unique because it uses tiny bubbles filled with oxygen to enhance tissue oxygenation, which can promote wound healing and has anti-inflammatory and antibacterial properties. Unlike traditional treatments, MNBs can deliver oxygen directly to tissues, potentially improving healing in areas with low oxygen levels. ^{1 2 3 8 9}

Research Team

Raj Vyas, MD

Principal Investigator

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Oxygen-Carrying Micro/Nanobubbles: Composition, Synthesis Techniques and Potential Prospects in Photo-Triggered Theranostics. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Bubble-Based Drug Delivery Systems: Next-Generation Diagnosis to Therapy. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Stability of Engineered Micro or Nanobubbles for Biomedical Applications. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Oxygen and air nanobubble water solution promote the growth of plants, fishes, and mice. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

NanoBubble-Mediated Oxygenation: Elucidating the Underlying Molecular Mechanisms in Hypoxia and Mitochondrial-Related Pathologies. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Investigation of anti-inflammatory effects of oxygen nanobubbles in a rat hydrochloric acid lung injury model. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

Proliferative effects of nanobubbles on fibroblasts. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Review of Oxygenation with Nanobubbles: Possible Treatment for Hypoxic COVID-19 Patients. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Beyond Oncological Hyperthermia: Physically Drivable Magnetic Nanobubbles as Novel Multipurpose Theranostic Carriers in the Central Nervous System. [2021]