Vein Expansion Techniques for High Blood Pressure

(OH Trial)

Overseen by Jian Cui

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Milton S. Hershey Medical Center

Disqualifiers: Chronic diseases, Orthostatic hypotension, Smoker, others

Trial Summary

What is the purpose of this trial?

This research is being done to find out whether distension of veins in legs will cause a rise in blood pressure (orthostatic hypertension).

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.

What data supports the effectiveness of the treatment Vein Expansion Techniques for High Blood Pressure?

Research shows that negative pressure wound therapy (NPWT) can improve blood flow and promote healing in chronic wounds, which suggests it might help with blood flow issues related to high blood pressure. Additionally, NPWT has been effective in reducing complications and improving healing rates in surgical and chronic wound settings, indicating potential benefits for similar vascular conditions. ^{1 2 3 4 5}

Is negative pressure wound therapy (NPWT) safe for humans?

Research on negative pressure wound therapy (NPWT) shows it is generally safe for humans, with studies reporting uncomplicated healing in high-risk patients, such as those with large sarcomas or after major limb amputations. However, more studies are needed to provide stronger evidence for its safety and effectiveness. ^{3 6 7 8 9}

Research Team

Jian Cui

Principal Investigator

Penn State College of Medicine

Eligibility Criteria

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.

I am 18 years old or older.

Are of any race or ethnicity

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

Trial Timeline

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

Treatment Details

Interventions

• Limb occlusion + negative pressure (Other)
• Limb occlusion + no negative pressure (Other)
• Tilt + external pressure (Other)
• Tilt + no external pressure (Other)

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.

Participant Groups

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+

Dr. Robert Harbaugh

Milton S. Hershey Medical Center

Chief Medical Officer since 2024

MD from Penn State College of Medicine

Don McKenna

Milton S. Hershey Medical Center

Chief Executive Officer since 2024

Master’s in Public Administration and Bachelor of Science in Business Administration and Marketing from Long Island University

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Negative pressure wound therapy as an adjunct to compression for healing chronic venous ulcers. [2011]

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

Incisional Application of Negative Pressure for Nontraumatic Lower Extremity Amputations: A Review. [2022]

3. United States 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. [2023]

4. Croatia pubmed.ncbi.nlm.nih.gov

[Role of negative pressure therapy in the treatment of chronic wounds]. [2012]

5. England pubmed.ncbi.nlm.nih.gov

Negative-pressure wound therapy for prevention and treatment of surgical-site infections after vascular surgery. [2017]

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

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

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

A Novel Use of Next-Generation Closed Incision Negative Pressure Wound Therapy After Major Limb Amputation and Amputation Revision. [2020]

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

Biomechanical Modeling of the Forces Applied to Closed Incisions During Single-Use Negative Pressure Wound Therapy. [2022]

9. France pubmed.ncbi.nlm.nih.gov

[Using negative pressure therapy to prevent and treat wounds]. [2018]