Inelastic Compression System for Chronic Venous Insufficiency

Overseen By Maria Muniz

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Active malignancy, Pregnant, Breastfeeding, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how an inelastic compression wrap affects the quality of life for people with chronic venous insufficiency (CVI). CVI occurs when blood doesn't flow properly in the veins, often causing leg swelling and discomfort. The trial will test the Sigvaris Compreflex Inelastic Compression Wrap to determine if it provides more relief than usual compression stockings, particularly for those dissatisfied with their current compression gear. Suitable candidates are adults with moderate to severe CVI who struggle to adhere to their current compression treatments. As an unphased trial, this study offers a unique opportunity to explore a new treatment option for enhancing daily comfort and quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It mainly focuses on the use of an inelastic compression system for chronic venous insufficiency.

What prior data suggests that this inelastic compression system is safe for patients with chronic venous insufficiency?

Research has shown that the Sigvaris Compreflex Inelastic Compression Wrap is generally safe for individuals with chronic venous insufficiency (CVI). Studies have found that these wraps can enhance quality of life by alleviating symptoms such as swelling and discomfort. Most users find the wraps comfortable and do not experience serious side effects.

The wrap fits various leg sizes and shapes, ensuring comfort and minimizing the risk of skin irritation. Its inelastic design provides steady, firm pressure, which improves blood flow without being overly tight.

Overall, the Sigvaris Compreflex Wrap is a safe and effective option for managing CVI, particularly for those who struggle with traditional compression stockings or bandages. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the traditional use of elastic compression stockings for chronic venous insufficiency, the Sigvaris Compreflex Inelastic Compression Wrap offers a different approach by providing consistent, adjustable pressure without the need for elastic materials. This inelastic wrap is designed for easier application and removal, which can be particularly beneficial for patients with limited mobility or dexterity. Researchers are excited about this treatment because it may improve patient adherence and comfort, potentially leading to better management of symptoms and improved quality of life for those with chronic venous insufficiency.

What evidence suggests that the Sigvaris Compreflex Inelastic Compression Wrap is effective for chronic venous insufficiency?

Research has shown that the Sigvaris Compreflex Inelastic Compression Wrap, used by participants in this trial, can improve symptoms for people with chronic venous insufficiency (CVI). In studies where patients used the wrap for six weeks, their quality of life improved. The wrap likely enhances blood flow in the legs by providing steady and strong pressure. It is also designed to be more comfortable and easier to use than traditional compression bandages, which may encourage adherence to treatment. Overall, these features make it a promising option for those dealing with CVI. ^{3 4 5 6 7}

Who Is on the Research Team?

Hadar Lev-Tov, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for adults over 18 with chronic venous insufficiency stages C3 to C5 who haven't been following their prescribed compression treatments. Participants must be willing to follow the study's procedures. Pregnant or breastfeeding individuals, those unable to comply with the study, and patients with active cancer (except non-melanoma skin cancer) cannot join.

Inclusion Criteria

I have chronic vein problems classified as moderate to severe.

I do not follow my prescribed compression therapy regimen.

Exclusion Criteria

Subjects who are pregnant and/or breastfeeding

In the opinion of the PI the subject cannot comply with study procedures

I have a cancer diagnosis other than non-melanoma skin cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the inelastic compression wrap for daily use on their legs

6 weeks

Follow-up

Participants are monitored for changes in quality of life after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sigvaris Compreflex Inelastic Compression Wrap

Trial Overview The trial is testing how an inelastic compression wrap, specifically the Sigvaris Compreflex, affects quality of life in patients not adhering to standard compression therapies for chronic venous insufficiency.

How Is the Trial Designed?

Group I: Inelastic Compression System Group Experimental Treatment 1 Intervention

Participants in this group will receive the inelastic compression wrap for daily use on their legs for 6 consecutive weeks.

Sigvaris Compreflex Inelastic Compression Wrap is already approved in United States, European Union for the following indications:

Approved in United States as Sigvaris Compreflex for:

• Chronic Venous Insufficiency (CVI)
• Lymphedema
• Non-specific or post-surgical edema

Approved in European Union as Sigvaris Compreflex for:

• Chronic Venous Disease
• Venous leg ulcers treatment
• Lymphedema
• Edema
• Lipedema

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Published Research Related to This Trial

Non-elastic compression treatments, like the Unna boot and CircAid legging, have been shown to effectively maintain limb size and reduce venous volume better than traditional elastic stockings, particularly in patients with severe chronic venous insufficiency.

Studies indicate that inelastic compression not only improves calf muscle pump function but also enhances microcirculation in the legs, potentially accelerating the healing of leg ulcers, similar to the effects of surgical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-elastic compression: an alternative in management of chronic venous insufficiency. Bergan, JJ., Sparks, SR.[2019]

The study evaluated six adjustable compression wraps (ACWs) in five healthy subjects, focusing on their stretch, interface pressures, and Static Stiffness Index (SSI), which are important for treating chronic venous diseases and lymphedema.

Results showed that inelastic ACWs like Coolflex® have a maximum pressure limit of 30 mmHg, while other wraps like Juxtafit® and Compreflex® can achieve pressures above 60 mmHg, indicating that the type of wrap and its stretch properties can significantly influence their effectiveness in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjustable compression wraps: stretch, interface pressures and static stiffness indices. Benigni, JP., Uhl, JF., Filori, P., et al.[2023]

A new modular compression stocking kit, designed for ease of use, was successfully donned by all 20 patients over 65 with chronic venous insufficiency (CVI), compared to only 60% of patients who could don a traditional strong compression stocking without assistance.

The pressure exerted by the new stocking kit was comparable to that of a strong compression stocking during rest, indicating it may provide similar therapeutic benefits while being more user-friendly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Compression Kit of a Stocking and Three Superimposed Leggings Is Easy to Don and Dose Adjustable. Luder, C., Dziunycz, P., Omid, N., et al.[2016]

The inelastic legging equipped with a pressure-adjustment system produced significantly higher skin surface pressures compared to the elastic stocking, with mean pressures of 50 mm Hg at the ankle versus 26 mm Hg for the elastic stocking.

Only the inelastic legging demonstrated significant gradient compression from the ankle to the knee, which is important for effective treatment of venous conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inelastic compression legging produces gradient compression and significantly higher skin surface pressures compared with an elastic compression stocking. Kline, CN., Macias, BR., Kraus, E., et al.[2019]

In a study involving 18 active patients with chronic venous insufficiency (CVI) stages II and III, three compression systems (Porelast, Rosidal Sys, and Coban) demonstrated high stiffness index values, indicating effective compression.

The Proguide system, however, showed lower stiffness and pressure levels, making it less effective compared to the other systems for treating advanced CVI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A short review of diagnosis and compression therapy of chronic venous insufficiency. Kecelj Leskovec, N., Pavlović, MD., Lunder, T.[2014]

In a study of 114 male workers with chronic venous insufficiency, wearing class II compression stockings for 3 months significantly reduced leg swelling and complaints compared to controls.

Rubber floor mats were less effective and often unsuitable for hygienic reasons, showing minimal impact on leg swelling and complaints, making compression stockings the superior choice for managing symptoms of CVI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compression stockings and rubber floor mats: do they benefit workers with chronic venous insufficiency and a standing profession? Krijnen, RM., de Boer, EM., Adèr, HJ., et al.[2019]

In a clinical trial involving 156 patients with venous leg ulcers, both a four-layer bandage system and a cohesive short-stretch system showed similar efficacy, with 69% and 73% ulcer closure rates respectively after 24 weeks.

The study found no significant difference in healing rates between the two bandage systems, indicating that either option is effective for managing venous leg ulceration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized trial of cohesive short-stretch versus four-layer bandaging in the management of venous ulceration. Franks, PJ., Moody, M., Moffatt, CJ., et al.[2006]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11989583/

The Effect of Inelastic Compression Wraps on the Quality ... The primary endpoint was the change in QoL over 6 weeks as measured by the Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20).

2. withpower.com withpower.com/trial/phase-venous-insufficiency-10-2021-d73ce

Inelastic Compression System for Chronic Venous ... The Sigvaris Compreflex Inelastic Compression Wrap is unique because it provides higher skin surface pressures and significant gradient compression from the ...

3. researchgate.net researchgate.net/publication/390298367_The_Effect_of_Inelastic_Compression_Wraps_on_the_Quality_of_Life_of_People_with_Chronic_Venous_Insufficiency_A_Single-Center_Single-Arm_Prospective_Study

The Effect of Inelastic Compression Wraps on the Quality ... The primary endpoint was the change in QoL over 6 weeks as measured by the Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20).

4. sigvaris.com sigvaris.com/en-us/campaigns/compreflex-comeback

Compreflex inelastic compression The Compreflex range of products are low profile compression devices designed to deliver measurable compression to the upper and lower extremeties.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/wrr.13078

Consistent application of compression: An under‐ ... Venous leg ulcers, the most common leg ulcer, occur in patients with chronic venous insufficiency due to venous hypertension.

6. sigvaris.com sigvaris.com/en-us/catalog/product-styles/inelastic-wraps

Inelastic wraps Our inelastic compression wraps are devices that cover your limbs tightly for a high range of adjustability, creating an accurate, custom fit.

7. sigvaris.com sigvaris.com/en-us/catalog/product-styles/inelastic-wraps/compreflex-standard-calf-

Compreflex Standard Calf The Compreflex Standard Calf is an inelastic compression device. Paired with the non-compressive Basic Liner, the Compreflex Standard Calf offers compression to ...