Oxygenation for Vascular Lesions

Overseen By Kristi Kearney, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Disqualifiers: Age < 18, Age > 90, Colon ulcerations, Previous colon surgery

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Oxygenation for Vascular Lesions?

Research shows that hyperbaric oxygen therapy, which involves breathing pure oxygen in a pressurized room, can improve healing in conditions like diabetic wounds, crush injuries, and tissue damage after radiation. It enhances oxygen delivery to tissues, promoting healing and reducing the risk of further damage. ^{1 2 3 4 5}

Is hyperbaric oxygen therapy safe for humans?

Hyperbaric oxygen therapy is generally considered safe for humans when used according to standard protocols, with few side effects like ear pressure discomfort, anxiety, and temporary vision changes. ^{1 3 6 7 8}

How is oxygen therapy different from other treatments for vascular lesions?

Oxygen therapy, specifically hyperbaric oxygen therapy, is unique because it involves breathing pure oxygen in a pressurized room, which increases the amount of oxygen in the blood and helps improve blood flow and tissue healing. This method is particularly useful for conditions where tissues are not getting enough oxygen, such as in severe vascular trauma or chronic arterial diseases, and it can enhance the effectiveness of other treatments like surgery. ^{1 9 10 11 12}

What is the purpose of this trial?

The goal of this clinical trial is to evaluate oxygenation in the colon in people with acquired vascular abnormalities in the proximal colon.

Research Team

Joel Pekow, MD

Principal Investigator

University of Chicago

Eligibility Criteria

This trial is for adults aged 18-89 who are undergoing a routine colonoscopy and either have a history of vascular lesions in the colon or have a healthy colon. It's not open to those under 18, over 90, with ulcerations at the ascending colon opposite the ileocecal valve, or who've had previous colon surgery.

Inclusion Criteria

My colon is healthy.

I will have a routine colonoscopy as part of my care.

I have had blood vessel issues in my colon.

Exclusion Criteria

I am under 18 years old.

I am over 90 years old.

I have ulcers in the upper part of my large intestine near the small intestine.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Evaluation

Participants undergo evaluation of colonic oxygen saturation levels

12 months

Regular visits for oxygen saturation measurement

Follow-up

Participants are monitored for safety and effectiveness after evaluation

4 weeks

Treatment Details

Interventions

• Oxygen saturation

Trial Overview The study aims to measure how well oxygen gets to parts of the large intestine (colon) in people with abnormal blood vessels there. This will be done during their standard care procedure for examining the inside of their large intestine.

Participant Groups

Group I: Vascular abnormality group Experimental Treatment 1 Intervention

People with acquired vascular abnormalities in the proximal colon

Group II: Control group Active Control 1 Intervention

People with healthy colon

Oxygen saturation is already approved in United States, European Union for the following indications:

Approved in United States as Oxygen therapy for:

• Respiratory distress
• Cardiovascular emergencies
• Carbon monoxide poisoning
• Decompression sickness

Approved in European Union as Oxygen therapy for:

• Respiratory failure
• Cardiac arrest
• Carbon monoxide poisoning
• Gas gangrene

Approved in United States as Hyperbaric oxygen therapy for:

• Carbon monoxide poisoning
• Decompression sickness
• Gas gangrene
• Crush injuries

Approved in European Union as Hyperbaric oxygen therapy for:

• Carbon monoxide poisoning
• Decompression sickness
• Gas gangrene
• Diabetic foot ulcers

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Findings from Research

In a study of 80 patients with arterial occlusive disease (AOD) and diabetic angiopathy (DA), those receiving hyperbaric oxygen (HBO) therapy in addition to standard treatment showed significantly better healing outcomes, with 9 patients improving compared to only 1 in the non-HBO group.

HBO therapy not only enhanced wound healing but also reduced the number of lower-limb amputations in patients with AOD and DA, supporting its clinical use for treating diabetic lower-extremity wounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Occlusive Arterial Disease and Diabetic Angiopathy Treatment Effects by Hyperbaric Oxygenation. Begić, A., Dilić, M.[2022]

Hyperbaric oxygen therapy can improve oxygen delivery to tissues affected by trauma, potentially reducing cell death and secondary ischemia in patients with crush injuries or compartment syndrome.

Recent studies have confirmed the efficacy of hyperbaric oxygen therapy in trauma patients, but further research is needed to establish optimal treatment protocols and additional uses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy in extremity trauma. Greensmith, JE.[2019]

Hyperbaric oxygen therapy (HBO) is effective in improving tissue oxygenation and promoting wound healing, making it a key treatment for conditions like severe carbon monoxide poisoning and diabetic foot wounds.

HBO is considered safe with minimal adverse effects when administered according to standard protocols, although further research is needed to explore its efficacy for other potential uses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Hyperbaric oxygen therapy (HBO): current standing]. Haltern, C., Siekmann, UP., Rump, AF., et al.[2006]

Inhalation of 100% oxygen under pressure, known as hyperbaric oxygen therapy, can significantly enhance healing by improving oxygen delivery to tissues, which promotes the growth of new blood vessels.

This therapy is particularly beneficial for patients suffering from conditions like tissue damage after radiation, refractory osteomyelitis, gas gangrene, and non-healing wounds, making it a valuable adjunctive treatment in these cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy. Promoting healing in difficult cases. Cohn, GH.[2019]

Hyperbaric oxygen therapy, which involves breathing 100% oxygen under high pressure, significantly increases the amount of oxygen available for cellular metabolism, leading to various beneficial effects that support healing in conditions like clostridial myonecrosis and chronic wounds.

While hyperbaric oxygen is now recognized as an effective adjunctive treatment for several medical conditions, further randomized controlled trials are needed to fully establish its efficacy and optimize its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Hyperbaric oxygen therapy in trauma surgery]. Mutschler, W., Muth, CM.[2019]

In a study of 2,334 patients undergoing hyperbaric oxygen (HBO2) therapy, 17.4% experienced adverse events, with the most common being middle ear barotrauma affecting 9.2% of patients.

Despite some side effects, the overall incidence of complications was low at 0.72% per session, indicating that with proper protocols and monitoring, HBO2 therapy is a safe treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of hyperbaric oxygen treatment--retrospective analysis in 2,334 patients. hadanny, A., Meir, O., Bechor, Y., et al.[2016]

Adjunctive hyperbaric oxygen therapy is a safe and effective treatment that can enhance healing in complicated acute wounds, flaps, and grafts when used alongside standard wound management practices, based on a review of eight relevant studies.

While hyperbaric oxygen therapy shows promise for improving healing in difficult cases, it is not recommended for normal wound management, indicating that more research is needed to establish its role as a standard treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does hyperbaric oxygen therapy work in facilitating acute wound healing: a systematic review. Dauwe, PB., Pulikkottil, BJ., Lavery, L., et al.[2022]

A study of 155 patients undergoing hyperbaric oxygen (HBO₂) therapy revealed that there is a measurable increase in blood pressure (systolic, diastolic, and mean arterial pressure) following treatment, although the increase is not large.

Patients taking calcium channel blockers and beta-blockers experienced greater increases in blood pressure, while those on ACE inhibitors had a protective effect, suggesting that medication type can influence blood pressure responses during HBO₂ therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of hyperbaric oxygen therapy on blood pressure in patients undergoing treatment. Heyboer Rd, M., Wojcik, SM., Smith, G., et al.[2019]

In a study involving 7 young, healthy individuals with severe vascular trauma, standard vascular repair alone did not restore adequate blood circulation, leaving the limbs ischaemic.

Hyperbaric oxygen treatment at pressures of 2-8 atm successfully prevented gangrene in all cases, suggesting it is a valuable addition to reconstructive vascular surgery, especially when performed later after injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen treatment as an adjuvant to reconstructive vascular surgery in trauma. Monies-Chass, I., Hashmonai, M., Hoere, D., et al.[2019]

Hyperbaric oxygen therapy (O.H.B.) was tested on 2,021 patients with limb arteriopathies from 1966 to 1983, showing no complications and a significant increase in oxygen levels in the blood, which may help treat these conditions.

In 40% of cases, O.H.B. facilitated the movement of blood from healthy areas to hypoxic (low oxygen) regions, suggesting it could be an effective treatment for asymptomatic arteriopathy by improving blood flow to affected areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Hyperbaric oxygenation and arteriopathies]. Fredenucci, P.[2013]

Hyperbaric oxygen therapy has been shown to effectively treat trauma-induced compartment syndrome, as demonstrated in a case where it reduced edema and improved tissue viability after surgical decompression.

The therapy works by enhancing oxygen delivery to tissues, which is crucial for recovery in conditions like compartment syndrome, suggesting it could be a valuable treatment option in similar acute traumatic injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjunctive treatment of compartment syndrome with hyperbaric oxygen. Fitzpatrick, DT., Murphy, PT., Bryce, M.[2017]

In a study of 115 patients undergoing coronary stent implantation, those who received hyperbaric oxygen (HBO2) therapy showed significant improvements in vascular endothelial function, indicated by higher levels of flow-mediated dilation (FMD), nitric oxide (NO), and calcitonin gene-related peptide (CGRP) compared to the control group.

HBO2 therapy also resulted in lower levels of high-sensitivity C-reactive protein (hs-CRP) and endothelin-1 (ET-1), suggesting it may help reduce inflammation and improve vascular health in patients with coronary artery disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen may improve vascular endothelial function in patients undergoing coronary stent implantation. Li, Y., Hao, YF., Wang, T., et al.[2019]

References

1. Bosnia and Herzegovina pubmed.ncbi.nlm.nih.gov

Evaluation of the Occlusive Arterial Disease and Diabetic Angiopathy Treatment Effects by Hyperbaric Oxygenation. [2022]

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

Hyperbaric oxygen therapy in extremity trauma. [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

[Hyperbaric oxygen therapy (HBO): current standing]. [2006]

4. England pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy. Promoting healing in difficult cases. [2019]

5. Germany pubmed.ncbi.nlm.nih.gov

[Hyperbaric oxygen therapy in trauma surgery]. [2019]

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

The safety of hyperbaric oxygen treatment--retrospective analysis in 2,334 patients. [2016]

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

Does hyperbaric oxygen therapy work in facilitating acute wound healing: a systematic review. [2022]

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

Effect of hyperbaric oxygen therapy on blood pressure in patients undergoing treatment. [2019]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen treatment as an adjuvant to reconstructive vascular surgery in trauma. [2019]

10. France pubmed.ncbi.nlm.nih.gov

[Hyperbaric oxygenation and arteriopathies]. [2013]

11. England pubmed.ncbi.nlm.nih.gov

Adjunctive treatment of compartment syndrome with hyperbaric oxygen. [2017]

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

Hyperbaric oxygen may improve vascular endothelial function in patients undergoing coronary stent implantation. [2019]