Vein Expansion Techniques for High Blood Pressure

(OH Trial)

Overseen By Kris Gray

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Milton S. Hershey Medical Center

Disqualifiers: Chronic diseases, Orthostatic hypotension, Smoker, others

Compensation: Varies

Number of Visits: 1

Duration: 4-5 hours per visit

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether expanding veins in the legs affects blood pressure when standing, a condition known as orthostatic hypertension. Participants will be divided into groups to test methods such as applying pressure or tilting the body, with or without additional pressure. Ideal candidates include those with stage I hypertension (mildly high blood pressure) who experience increased blood pressure when standing, or those without major health issues. As an unphased trial, this study provides a unique opportunity to contribute to understanding innovative methods for managing blood pressure.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have stage I hypertension, you may be included in the study, suggesting that some medications might be allowed.

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

Research has shown that tilt tests, such as the tilt with external pressure treatment, are generally safe. These tests have been used for many years to understand why people faint or feel dizzy. Although mostly safe, some individuals might feel uncomfortable due to reduced blood flow to the heart during the test.

For the limb occlusion with negative pressure method, studies indicate that negative pressure is often used safely in wound healing treatments. It works by applying gentle suction to aid healing. While usually safe, monitoring its use is important to prevent any issues.

Overall, these treatments have been used in other medical settings and are generally well-tolerated. However, like any treatment, risks exist, so staying informed and asking questions is crucial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Vein Expansion Techniques for High Blood Pressure trial because it explores innovative, non-pharmacological methods to manage hypertension. Unlike standard medications that often focus on reducing blood volume or dilating blood vessels, this trial investigates physical interventions like limb occlusion and body tilting combined with pressures to influence blood flow and pressure. These techniques could offer a new way to manage blood pressure without the side effects of drugs, potentially benefiting those who prefer or require non-drug therapies. Additionally, by using methods like negative pressure or external pressure, researchers aim to understand how mechanical changes in the body can directly impact blood pressure regulation. This trial could pave the way for alternative treatments that are both effective and less dependent on medication.

What evidence suggests that this trial's treatments could be effective for high blood pressure?

This trial will compare different vein expansion techniques for high blood pressure. Research has shown that the head-up tilt test (HUTT), which participants in this trial may undergo, is useful for studying how blood pressure changes when someone stands up. During this test, blood pressure can drop significantly, aiding in understanding blood pressure control. The tilt test has been safely used for many years to observe how the heart and blood vessels react to different positions.

Another technique under study in this trial is limb occlusion with negative pressure. Research indicates that using negative pressure on the limbs can greatly increase blood flow. Specifically, one study found that skin blood flow increased by 89% shortly after applying negative pressure. This suggests that combining limb occlusion with negative pressure might effectively influence blood pressure responses. ^{6 7 8 9 10}

Who Is on the Research Team?

Jian Cui

Principal Investigator

Penn State College of Medicine

Are You a Good Fit for This Trial?

This trial is for adults over 18 who can consent and speak English. It's for those with a specific type of high blood pressure that increases when standing, or normal blood pressure individuals matched by gender, age, and body size to the first group. Pregnant women, smokers, people with chronic diseases other than stage I hypertension, or history of blood clots are excluded.

Inclusion Criteria

My blood pressure stays almost the same when I stand up, and I'm healthy with no chronic conditions.

Are of any race or ethnicity

I understand the study and can agree to participate.

Exclusion Criteria

Are a pregnant or nursing woman

I have had blood clots in the past.

Are a prisoner or institutionalized individual or unable to consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo experimental models involving limb occlusion and negative pressure to study the venous distension reflex and its impact on blood pressure and sympathetic nerve activity

4-5 hours per visit

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Limb occlusion + negative pressure
• Limb occlusion + no negative pressure
• Tilt + external pressure
• Tilt + no external pressure

Trial Overview

The study tests if leg vein distension affects blood pressure during changes in posture. Participants will experience limb occlusion (blocking blood flow) with or without negative pressure and tilting with or without external pressure to simulate these conditions.

How Is the Trial Designed?

Group I: Tilt + external pressure Experimental Treatment 1 Intervention

Tilt + external pressure on legs performed in both "BP elevated with standing" and "BP maintained with standing" groups.

Group II: Limb occlusion + negative pressure Experimental Treatment 1 Intervention

Limb occlusion + negative pressure performed in both "BP elevated with standing" and "BP maintained with standing" groups.

Group III: Tilt + no external pressure Placebo Group 1 Intervention

Tilt + no external pressure performed in both "BP elevated with standing" and "BP maintained with standing" groups.

Group IV: Limb occlusion + no negative pressure Placebo Group 1 Intervention

Limb occlusion + no negative pressure performed in both "BP elevated with standing" and "BP maintained with standing" groups.

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials

515

Recruited

2,873,000+

Published Research Related to This Trial

Negative pressure wound therapy (NPWT) has been successfully applied to closed incisions, showing promise in improving wound healing for high-risk surgical patients, particularly those with large sarcomas that have been previously radiated.

In two case reports, the use of closed-incision negative pressure therapy (ciNPT) resulted in uncomplicated healing, suggesting its potential effectiveness, although further clinical trials are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Closed Incision Negative Pressure Wound Therapy After Resection of Large, Radiated, Soft Tissue Sarcomas. Irwin, TJ., Orgill, D.[2020]

Negative-pressure wound therapy (NPWT) significantly accelerates wound healing in open infected groin wounds, reducing healing time by an average of 47 days compared to traditional dressings, and is more cost-effective than alginate dressings.

In vascular surgery, NPWT is associated with high rates of graft preservation (83-100%) and a significant reduction in surgical-site infections, dropping from 30% with standard care to just 6% with closed incisional NPWT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Negative-pressure wound therapy for prevention and treatment of surgical-site infections after vascular surgery. Acosta, S., Björck, M., Wanhainen, A.[2017]

Negative Pressure Wound Therapy (NPWT) has become increasingly available, offering a variety of devices including motorized pumps, portable options, and automated therapies for specific wound types.

The growing diversity of NPWT devices necessitates detailed prescriptions from medical professionals and careful tracking of nursing follow-up to ensure effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Using negative pressure therapy to prevent and treat wounds]. Nicodème, M., Chéron, M., Fromantin, I.[2018]

Next-generation incisional negative pressure wound therapy (iNPWT) was successfully used after major limb amputation or revision, leading to uncomplicated healing in the reported cases.

This innovative application of iNPWT improved incision healing, reduced residual limb edema, and lowered the risk of surgical site infections, highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Use of Next-Generation Closed Incision Negative Pressure Wound Therapy After Major Limb Amputation and Amputation Revision. West, J., Wetherhold, J., Schulz, S., et al.[2020]

Negative pressure wound therapy (NPWT) significantly reduces the lateral tension on closed surgical incisions, with forces on individual sutures dropping to as low as 31% of normal levels at -80 mm Hg pressure, which may help prevent complications like surgical site infections.

Biomechanical testing indicates that at -80 mm Hg, NPWT requires 55% more force to deform the tissue compared to no therapy, suggesting that effective tension reduction occurs primarily at this pressure level, supporting its clinical benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomechanical Modeling of the Forces Applied to Closed Incisions During Single-Use Negative Pressure Wound Therapy. Loveluck, J., Copeland, T., Hill, J., et al.[2022]

Incisional negative-pressure wound therapy (iNPWT) significantly reduces the rates of incisional infections and the need for revisional surgeries in high-risk patients, with infection rates dropping from 48% to 7% and revisional surgery rates from 48% to 7%.

While iNPWT shows promise in decreasing complications and potentially improving healing after lower-extremity amputations, further prospective randomized trials are necessary to confirm its benefits on morbidity, function, and mortality rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incisional Application of Negative Pressure for Nontraumatic Lower Extremity Amputations: A Review. Kotha, V., Walter, E., Stimac, G., et al.[2022]

In a pilot study involving seven patients with 12 chronic resistant venous ulcers, the combination of negative pressure wound therapy (NPWT) and compression bandaging showed promising results, with ulcers rapidly progressing to healthy, granulating wounds over 12 weeks.

This treatment approach may effectively stimulate healing in chronic venous ulcers and could also prepare these wounds for potential skin grafting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Negative pressure wound therapy as an adjunct to compression for healing chronic venous ulcers. Kieser, DC., Roake, JA., Hammond, C., et al.[2011]

Negative Pressure Wound Therapy (NPWT) effectively enhances chronic wound healing by promoting blood flow, reducing edema, and stimulating granulation tissue formation, with negative pressure levels between 40 and 125 mm Hg.

NPWT not only accelerates healing times compared to other treatments but also significantly reduces bacterial burden and harmful substances in the wound, making it a versatile option for both inpatient and outpatient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Role of negative pressure therapy in the treatment of chronic wounds]. Huljev, D., Gajić, A., Gverić, T., et al.[2012]

The low-cost AquaVac negative-pressure wound therapy (NPWT) system was found to be comparable to the commercially available VAC ATS system in terms of wound healing outcomes, such as exudate levels and granulation tissue formation, based on a study involving 36 patients.

AquaVac was significantly more affordable, costing $63.75 compared to $491.38 for the VAC ATS, making it a viable and effective alternative for NPWT in resource-limited settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wound-Healing Following Negative-Pressure Wound Therapy with Use of a Locally Developed AquaVac System as Compared with the Vacuum-Assisted Closure (VAC) System. Cocjin, HGB., Jingco, JKP., Tumaneng, FDC., et al.[2023]

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Applying higher relative pressures results in the greatest cardiovascular response, higher perceptual ratings, and greater decrease in exercise volume.

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The purpose of this study is to investigate if the embedded and distal methods of LOP measurement have clinically acceptable agreement.

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These results support earlier RCT data that NWPT is an effective and safe adjunct therapy in the management of diabetic foot ulcers. An updated ...

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It is currently recommended that tourniquet pressure be applied on an individual basis at 40%–80% of the user's limb occlusion pressure (LOP; ...

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Recent retrospective studies show that Negative Pressure Wound Therapy (NPWT) may have beneficial effects on incisional healing following lower limb amputations ...