Low Thermal Plasma for Marginal Ulcers

(AMULET Trial)

Overseen By Michele B. Ryan, MS

Age: 18+

Sex: Any

Trial Phase: Academic

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 All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for marginal ulcers, painful sores that can develop after weight loss surgeries like gastric bypass. The study compares a new method using Low Thermal Plasma (LTP) treatment to the usual treatment with medications called PPIs. People who have had a gastric bypass and experience symptoms like stomach pain, nausea, or difficulty swallowing might be suitable candidates. The researchers aim to demonstrate that LTP is less invasive and more effective than surgery for healing these ulcers. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance future treatment options.

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 prior data suggests that Low Thermal Plasma treatment is safe for marginal ulcers?

Research has shown that Low Thermal Plasma (LTP) treatment has been safely used in various medical fields. Studies have found it effective for controlling bleeding in ulcers and removing cancerous tissues, indicating that LTP is generally well-tolerated in these cases. While some studies have not found significant clinical benefits in wound treatment, other research highlights LTP's success in speeding up wound healing and reducing wound size. Overall, LTP is generally considered safe, with some potential benefits for healing. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Low Thermal Plasma (LTP) treatment for marginal ulcers because it offers a new way to enhance healing by using plasma energy to target the ulcer directly. While standard care for marginal ulcers typically involves proton pump inhibitors (PPIs) to reduce stomach acid, LTP aims to promote tissue regeneration at the site of the ulcer itself. This innovative approach could potentially accelerate healing and improve outcomes for patients, setting it apart from conventional treatments that primarily focus on symptom management.

What evidence suggests that Low Thermal Plasma is effective for treating marginal ulcers?

Research has shown that Low Thermal Plasma (LTP), which participants in this trial may receive, effectively heals various ulcers and wounds, including pressure sores and recurring mouth ulcers. One study found that LTP helped wounds heal by reducing their size and speeding up recovery. Another study demonstrated that cold atmospheric plasma, similar to LTP, also accelerated wound healing. LTP has been used safely and effectively to manage bleeding ulcers and remove cancerous tissue. These findings suggest that LTP could help treat marginal ulcers by promoting quicker healing. ^{1 2 4 6 7}

Who Is on the Research Team?

Christopher Thompson, MD

Principal Investigator

Brigham and Womens Hospital

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Low Thermal Plasma (LTP) Treatment

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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) 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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06543316?cond=%22Stomach%20Ulcer%22&aggFilters=status:not%20rec&rank=9

Marginal Ulcer Healing With Low-Thermal Argon Plasma ... It has demonstrated clinical safety and efficacy in many areas, including bleeding management (e.g., bleeding ulcers), ablation of cancerous tissue, and precise ...

2. withpower.com withpower.com/trial/phase-ulcer-10-2024-3aec0

Low Thermal Plasma for Marginal Ulcers (AMULET Trial) 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 ...

3. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/15347346251323940

The Efficacy of Low-Temperature Atmospheric-Pressure ... LTAPP showed outstanding performance in treating pressure ulcer wounds. The LTAPP gave greater outcome in wound size, wound healing indicators, ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06543316/marginal-ulcer-healing-with-low-thermal-argon-plasma-endoscopic-treatment

Marginal Ulcer Healing With Low-Thermal Argon Plasma ... The objective of the study is to investigate the treatment of marginal ulcers with Low Thermal plasma in an endoscopic setting.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7366186/

Effect of Cold Atmospheric Plasma Therapy vs Standard ... In this study, the application of cold atmospheric plasma resulted in improvement in wound healing, which is associated with earlier transition ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7379569/

Effects and safety of atmospheric low‐temperature plasma on ... Use of AP for treatment of wounds is safe, but the current evidence shows that there is no clinical benefit of AP in wound care using currently applied ...

7. nature.com nature.com/articles/s41598-018-24049-z

In vivo study of non-invasive effects of non-thermal plasma ... The plasma treatment also resulted in significant wound contraction and acceleration of wound healing. The findings of present study indicate ...