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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this protocol is to measure the effect of the use of an inelastic compression system (ICS) on quality of life (QOL) in patients with chronic venous insufficiency (CVI) who have demonstrated limited or no compliance with prescribed compression stockings or bandage wraps.

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.

Is the inelastic compression system safe for humans?

The studies reviewed do not provide specific safety data for the inelastic compression system, but they do not report any safety concerns for similar compression products used in humans. ^{1 2 3 4 5}

How does the Sigvaris Compreflex Inelastic Compression Wrap treatment differ from other treatments for chronic venous insufficiency?

The Sigvaris Compreflex Inelastic Compression Wrap is unique because it provides higher skin surface pressures and significant gradient compression from the ankle to the knee compared to traditional elastic compression stockings. This inelastic wrap mimics the action of the Unna boot, offering better maintenance of limb size and improved venous circulation, which can enhance healing and reduce symptoms more effectively than elastic options. ^{1 3 4 6 7}

Research Team

Hadar Lev-Tov, MD

Principal Investigator

University of Miami

Eligibility Criteria

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.

I am 18 or older, agree to participate, and will follow the study rules.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Adjustable compression wraps: stretch, interface pressures and static stiffness indices. [2023]

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

Randomized trial of cohesive short-stretch versus four-layer bandaging in the management of venous ulceration. [2006]

3. England pubmed.ncbi.nlm.nih.gov

Inelastic compression legging produces gradient compression and significantly higher skin surface pressures compared with an elastic compression stocking. [2019]

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

Compression stockings and rubber floor mats: do they benefit workers with chronic venous insufficiency and a standing profession? [2019]

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

A Compression Kit of a Stocking and Three Superimposed Leggings Is Easy to Don and Dose Adjustable. [2016]

6. Slovenia pubmed.ncbi.nlm.nih.gov

A short review of diagnosis and compression therapy of chronic venous insufficiency. [2014]

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

Non-elastic compression: an alternative in management of chronic venous insufficiency. [2019]