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Inelastic Compression System

Inelastic Compression System for Chronic Venous Insufficiency

N/A

Recruiting

Led By Hadar Lev-Tov, MD

Research Sponsored by University of Miami

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 6 weeks

Awards & highlights

Study Summary

This trial will test whether an inelastic compression system can improve quality of life for patients with chronic venous insufficiency who have not responded well to compression stockings or bandage wraps.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects are not listed, typical issues with compression wraps may include discomfort, skin irritation or breakdown if improperly used. The study aims to ensure proper use and monitor any adverse effects on participants.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in the Quality of Life as measured by CIVIQ-20

Trial Design

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor

902 Previous Clinical Trials

410,046 Total Patients Enrolled

Hadar Lev-Tov, MDPrincipal InvestigatorUniversity of Miami

8 Previous Clinical Trials

200 Total Patients Enrolled

Media Library

Sigvaris Compreflex Inelastic Compression Wrap (Inelastic Compression System) Clinical Trial Eligibility Overview. Trial Name: NCT05051540 — N/A

Chronic Venous Insufficiency Research Study Groups: Inelastic Compression System Group

Chronic Venous Insufficiency Clinical Trial 2023: Sigvaris Compreflex Inelastic Compression Wrap Highlights & Side Effects. Trial Name: NCT05051540 — N/A

Sigvaris Compreflex Inelastic Compression Wrap (Inelastic Compression System) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05051540 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment phase of this clinical trial currently open to participants?

"As per the data published on clinicaltrials.gov, this clinical trial is actively recruiting patients and has been edited as recently as May 9th 2022 after its initial posting of November 15 2021."

Answered by AI

What is the scope of involvement in this research project?

"Affirmative, the information on clinicaltrials.gov indicates that this study is currently enrolling patients. It was initially posted in November 2021 and most recently updated in May 2022, with a target recruitment of 30 individuals from one site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Effect of Inelastic Compression System on Quality of Life in People With Chronic Venous Insufficiency

Hadar Lev-Tov 2021. "The Effect of Inelastic Compression System on Quality of Life in People With Chronic Venous Insufficiency". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05051540.