Inelastic Compression System for Chronic Venous Insufficiency
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Miami
Disqualifiers: Active malignancy, Pregnant, Breastfeeding, others
No Placebo Group
Approved in 3 Jurisdictions
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?
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.13467
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.
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Trial 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 (Inelastic Compression System)
Trial OverviewThe 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
1Treatment groups
Experimental Treatment
Group I: Inelastic Compression System GroupExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MiamiMiami, FL
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Who Is Running the Clinical Trial?
University of Miami
Lead Sponsor
Trials
976
Patients Recruited
423,000+
References
Adjustable compression wraps: stretch, interface pressures and static stiffness indices. [2023]Adjustable compression wraps (ACWs) may represent the future of compression for the treatment of the most severe stages of chronic venous diseases and lymphedema. We tested in five healthy subjects: Coolflex® from Sigvaris®; Juzo wrap 6000®, Readywrap® from Lohmann Rauscher®; Juxtafit® and Juxtalite® from Medi®, Compreflex® from Sigvaris®. The objective of this pilot study was to study the stretch, interface pressures, and Static Stiffness Index (SSI) of the six ACWs applied to the leg.
Randomized trial of cohesive short-stretch versus four-layer bandaging in the management of venous ulceration. [2006]A multicenter prospective randomized clinical trial was undertaken to compare a generic four-layer bandage system with a cohesive short-stretch system (Actico, Activa Healthcare) in the management of venous leg ulceration. Both systems are designed to produce sufficient pressure to counteract venous hypertension. Patients in leg ulcer services with leg ulceration were screened for inclusion in this trial. Patients with arterial disease (ankle brachial pressure index
Inelastic compression legging produces gradient compression and significantly higher skin surface pressures compared with an elastic compression stocking. [2019]The purposes of this study were to (1) investigate compression levels beneath an inelastic legging equipped with a new pressure-adjustment system, (2) compare the inelastic compression levels with those provided by a well-known elastic stocking, and (3) evaluate each support's gradient compression production. Eighteen subjects without venous reflux and 12 patients with previously documented venous reflux received elastic and inelastic compression supports sized for the individual. Skin surface pressures under the elastic (Sigvaris 500, 30-40 mm Hg range, Sigvaris, Inc., Peachtree City, GA) and inelastic (CircAid C3 with Built-in-Pressure System [BPS], CircAid Medical Products, San Diego, CA) supports were measured using a calibrated Tekscan I-Scan device (Tekscan, Inc., Boston, MA). The elastic stocking produced significantly lower skin surface pressures than the inelastic legging. Mean pressures (+/- standard error) beneath the elastic stocking were 26 +/- 2 and 23 +/- 1 mm Hg at the ankle and below-knee regions, respectively. Mean pressures (+/- standard error) beneath the inelastic legging with the BPS were 50 +/- 3 and 38 +/- 2 mm Hg at the ankle and below-knee regions, respectively. Importantly, our study indicates that only the inelastic legging with the BPS produces significant ankle to knee gradient compression (p = .001).
Compression stockings and rubber floor mats: do they benefit workers with chronic venous insufficiency and a standing profession? [2019]Chronic venous insufficiency (CVI) is a burden to many workers, especially to those with a standing profession. Preventive measures are seldom taken. A quasirandomized parallel group trial was performed in 114 male workers with CVI and a standing profession. For 3 months, class II compression stockings or rubber floor mats were used vs controls. Outcome measures were diurnal volume changes (leg swelling) and complaints of the lower legs. With the stockings, a significant decrease in complaints was found, as well as a significant decrease in leg swelling. Rubber mats were often not suitable for hygienic and safety reasons. The decrease in complaints in the group using rubber mats was less pronounced, and leg swelling did not differ from that of the control group. Compression stockings appeared to be superior to rubber mats with regard to applicability, diminishing subjective complaints, and decrease of diurnal leg swelling.
A Compression Kit of a Stocking and Three Superimposed Leggings Is Easy to Don and Dose Adjustable. [2016]Forty percent of patients with chronic venous insufficiency (CVI) do not wear their indicated and prescribed compression stockings. Difficulties in donning and a feeling of constraint are the most common reasons for non-adherence.
A short review of diagnosis and compression therapy of chronic venous insufficiency. [2014]Chronic venous insufficiency (CVI) is a venous disorder in the lower extremities associated with changes in the skin and subcutaneous tissue. Treatment with short-stretch compression bandages is highly recommended for advanced stages of CVI.
Non-elastic compression: an alternative in management of chronic venous insufficiency. [2019]Non-elastic compression has been used to treat venous insufficiency of the lower extremities for more than 150 years. The best and most recognized example is the Unna boot. When compared with other dressings, the Unna boot has performed as well as or better than other forms of compression. While the Unna boot is used worldwide, a 3- or 4-layer dressing has emerged as the dressing of choice in treating severe chronic venous insufficiency in the United States and English-speaking European countries. In the United States, non-elastic compression can also be applied as a CircAid legging. This semirigid support has been compared with heavyweight class 3 below-knee medical stockings. At 2 and 6 hours after application, inelastic compression maintained limb size and reduced venous volume better than did stockings. At 6 hours, the ejection fraction of the calf muscle pump was increased and venous filling index significantly improved with inelastic compression compared with stockings. Comparison of elastic stockings with short-stretch bandages has also been completed. The short-stretch bandage was found to be similar but not identical to the semirigid inelastic support device. The studies have shown that venous filling index improved by short-stretch bandaging and that venous reflux time was prolonged more by the short-stretch bandages than by stockings. The findings of these studies demonstrate that the inelastic support dressing mimics the action of the Unna boot in providing counter-pressure to perforating vein outflow. This may improve cutaneous and subcutaneous microcirculation in a manner similar to perforating vein surgery, which has been shown to accelerate leg ulcer healing.