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Search / Trial NCT06350695

The ROle of Compression StocKings in Heart Failure Patients

Launched by UNIVERSITY OF MARYLAND, BALTIMORE · Apr 1, 2024

Trial Information

Current as of July 09, 2025

Recruiting

Keywords

Compression Stockings Congestive Heart Failure Venous Insufficiency Edema Of The Legs Venous Ulcers

ClinConnect Summary

This clinical trial is studying the use of compression stockings in patients with heart failure, specifically looking at how effective they are in reducing swelling in the legs and preventing skin problems. Heart failure can cause fluid buildup, leading to swollen legs, and while medications called diuretics are common treatments, they don’t always work for everyone. The trial will compare two types of knee-high socks: tight compression socks and soft socks with minimal compression, to see which is better for managing leg swelling and ensuring safety for patients with heart failure.

To participate, individuals must be at least 18 years old and diagnosed with heart failure that causes swelling in the legs. Participants will be randomly assigned to wear either the tight or soft socks for at least 8 hours a day, five days a week, over three months. They will attend an initial in-person visit for health assessments and then have three follow-up virtual visits, with another in-person checkup at the end of the study. This trial is currently recruiting and welcomes all eligible individuals within the specified age range who meet the inclusion criteria.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Age 18 years and older
  • Diagnosis of Heart failure NYHA II-III Class A, B, or C.
  • Pitting edema of the lower extremities
  • Exclusion Criteria:
  • Peripheral arterial disease with ABI of 0.5 or less
  • Severe decompensated heart failure NYHA IV
  • Unstable acute coronary syndrome
  • Severe valvular stenosis or regurgitation
  • Hypertrophic obstructive cardiomyopathy
  • Unstable arrhythmia without a defibrillator
  • On renal replacement therapy, hemodialysis of peritoneal dialysis
  • Morbid obesity with a BMI \> 40
  • Pregnancy
  • Lymphedema or Lipoedema
  • Unable to put the compression stockings on by him/ herself or a person to do it for the patient
  • Septic phlebitis, acute bacterial, viral or allergic inflammation of the legs
  • Expectancy of life less than 6 months
  • Unable to read or understand English language

About University Of Maryland, Baltimore

The University of Maryland, Baltimore (UMB) is a leading academic institution dedicated to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, UMB leverages its extensive resources and expertise across various disciplines, including medicine, pharmacy, nursing, and social work, to contribute to groundbreaking discoveries and improve patient outcomes. Committed to ethical research practices and collaboration, UMB fosters an environment that promotes the translation of scientific knowledge into real-world applications, ultimately enhancing the well-being of diverse populations.

Locations

Baltimore, Maryland, United States

Dallas, Texas, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported