Low Thermal Plasma for Marginal Ulcers

(AMULET Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Christopher Thompson, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Christopher C. Thompson, MD, MSc

Must be taking: PPIs

Must not be taking: Systemic antibiotics

Disqualifiers: Pregnancy, Lactation, Other trials, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The objective of the study is to investigate the treatment of marginal ulcers with Low Thermal plasma in an endoscopic setting. By a treatment of the ulcerated areas with argon plasma with low power settings (\~ 1 W) we hypothesize that the size of the ulcers will shrink, and the healing is accelerated compared to standard of care alone. Patients will benefit from this minimally invasive approach compared to a much more invasive surgical approach that comes with higher risks and hospital stay length time. From a societal and scientific perspective, this study aims to extend the well-documented clinical benefits of plasma technology - from external wound healing to internal ulcer treatment - within an endoscopic framework. The success of this study could pave the way for broader applications of LTP in the treatment of other endoscopically accessible conditions such as peptic ulcers, duodenal ulcers and esophageal ulcers. This advancement has the potential not only to improve patient outcomes through less invasive methods, but also to position LTP as a cornerstone in the future of gastroenterological wound management strategies.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be willing to follow the standard treatment, which includes taking PPIs (medications that reduce stomach acid). If you are currently using systemic antibiotics, you cannot participate in the trial.

What data supports the effectiveness of the Low Thermal Plasma (LTP) treatment for marginal ulcers?

Research shows that Low Thermal Plasma (LTP) is effective in healing various types of ulcers and wounds, such as pressure ulcers and recurrent oral ulcers, by promoting wound healing and reducing bacteria. This suggests it could also be beneficial for treating marginal ulcers. ^{1 2 3 4 5}

How is the Low Thermal Plasma treatment different from other treatments for marginal ulcers?

Low Thermal Plasma (LTP) treatment is unique because it uses a special type of gas that creates reactive particles at low temperatures, which can help heal wounds and reduce bacteria. Unlike traditional treatments, LTP can be applied directly to the ulcer and works by promoting healing and reducing infection without the need for high temperatures or harsh chemicals. ^{1 2 3 4 6}

Research Team

Christopher Thompson, MD

Principal Investigator

Brigham and Womens Hospital

Eligibility Criteria

This trial is for individuals with marginal ulcers, which can cause symptoms like gastrointestinal bleeding, vomiting, abdominal pain, and difficulty swallowing. Participants should have a history of Roux-en-Y anastomosis surgery that led to these ulcers.

Inclusion Criteria

I understand the study's requirements and can give informed consent.

I can attend follow-up visits 4 and 8 weeks after treatment.

I can undergo multiple endoscopies.

Exclusion Criteria

I am unable to understand or sign the consent form.

Inability or unwillingness to comply with the SOC

My doctor thinks an endoscopy could be unsafe for me.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Low Thermal Plasma (LTP) treatment of the ulcer in addition to standard of care (PPI administration) or only the standard of care treatment (PPI administration).

8 weeks

Baseline, 4 weeks, 8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including ulcer healing success rate and improvement of tissue oxygenation.

8 weeks

Baseline, 4 weeks, 8 weeks

Treatment Details

Interventions

• Low Thermal Plasma (LTP) Treatment (Procedure)

Trial Overview The study compares Low Thermal Plasma (LTP) treatment applied endoscopically to the ulcerated areas against standard care (typically PPIs). The goal is to see if LTP speeds up healing and reduces ulcer size more effectively than standard treatments.

Participant Groups

Group I: Low Thermal Plasma (LTP) Active Control 2 Interventions

Patients randomized to this group will receive LTP treatment of the ulcer in addition to SOC (PPI administration).

Group II: Standard of Care (SOC) PPI Administration Active Control 1 Intervention

Patients randomized to this group will receive only the SOC treatment (PPI administration).

Who Is Running the Clinical Trial?

Christopher C. Thompson, MD, MSc

Lead Sponsor

Trials

6

Recruited

5,300+

Erbe USA Incorporated

Collaborator

Trials

12

Recruited

1,300+

Findings from Research

In a study involving 50 patients with pressure ulcers, treatment with low-temperature atmospheric-pressure plasma (LTAPP) in addition to standard care resulted in significantly better healing scores and reduced exudate after just one week.

LTAPP also demonstrated antimicrobial effects, leading to a reduction in bacterial load after a single treatment, highlighting its potential as an effective intervention for chronic wound management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Healing Effect of Low-Temperature Atmospheric-Pressure Plasma in Pressure Ulcer: A Randomized Controlled Trial. Chuangsuwanich, A., Assadamongkol, T., Boonyawan, D.[2018]

Low energy plasma treatment has shown antimicrobial and hemostatic properties, making it effective for local treatment of purulent and long-standing wounds as well as trophic ulcers.

In a study involving 113 patients, low energy plasma was found to stimulate regenerative processes, suggesting it can enhance healing in difficult-to-treat wounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Local application of low-energy aerial and argon plasma in the treatment of suppurative wounds and trophic ulcers]. Khrupkin, VI., Zudilin, AV., Pisarenko, LV., et al.[2006]

Low-temperature plasma (LTP) is a highly reactive tool that can be used safely in various biomedical applications, including treating infections, wounds, and even assisting in cancer treatment.

LTP generates reactive oxygen and nitrogen species, which are effective in altering surfaces and combating oral biofilm-related infections, showcasing its potential in optimizing medical treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive biomedical applications of low temperature plasmas. Duarte, S., Panariello, BHD.[2023]

Low temperature plasma (LTP) treatment significantly enhances the migration and growth factor production in human keratinocytes, which are crucial for wound healing, without causing cell toxicity.

LTP treatment increases the expression of hypoxia inducible factor-1α (HIF-1α), which plays a key role in promoting angiogenesis, suggesting that LTP could be a promising method to improve wound healing outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wound Healing Potential of Low Temperature Plasma in Human Primary Epidermal Keratinocytes. Cui, HS., Cho, YS., Joo, SY., et al.[2020]

Non-thermal plasma (NTP) treatment for recurrent ulcers in the mouth significantly reduced pain and inflammation without the need for additional medications, based on a study of 30 ulcers in patients averaging 37 years old.

The treatment led to tissue regeneration in an average of three days, demonstrating NTP as a promising and effective alternative for managing recurrent aphthous stomatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healing of Recurrent Aphthous Stomatitis by Non-Thermal Plasma: Pilot Study. Ibáñez-Mancera, NG., López-Callejas, R., Toral-Rizo, VH., et al.[2023]

Low temperature plasma (LTP) treatment significantly reduces the vitality, proliferation, invasion, and migration of breast cancer SK-BR-3 cells, indicating its potential as an anti-cancer therapy.

LTP induces apoptosis in SK-BR-3 cells in a time-dependent manner, suggesting that longer exposure to LTP enhances its effectiveness in targeting breast cancer cells.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low temperature plasma suppresses proliferation, invasion, migration and survival of SK-BR-3 breast cancer cells. Li, X., Sun, T., Zhang, X., et al.[2023]

References

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

The Healing Effect of Low-Temperature Atmospheric-Pressure Plasma in Pressure Ulcer: A Randomized Controlled Trial. [2018]

2. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Local application of low-energy aerial and argon plasma in the treatment of suppurative wounds and trophic ulcers]. [2006]

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

Comprehensive biomedical applications of low temperature plasmas. [2023]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Wound Healing Potential of Low Temperature Plasma in Human Primary Epidermal Keratinocytes. [2020]

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

Healing of Recurrent Aphthous Stomatitis by Non-Thermal Plasma: Pilot Study. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Low temperature plasma suppresses proliferation, invasion, migration and survival of SK-BR-3 breast cancer cells. [2023]