Compliance of Compression Therapy in Healed Venous Ulcerations

University Hospitals Cleveland Medical Center

Overview

This study seeks to determine if compliance with compression therapy is increased in patients with healed venous insufficiency ulcerations when lower levels of compression therapy are prescribed. This study will measure compliance with compression therapy at low levels of compression. It will also seek to determine if compression therapy aids in the prevention of venous insufficiency ulcer recurrence.

This study looks to determine if patients with a history of venous insufficiency and recently healed venous insufficiency ulcerations are compliant with lower levels of compression therapy. It also seeks to evaluate the efficacy of compression therapy in the prevention of recurrence of venous insufficiency ulcerations.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Conditions

Venous Insufficiency

Interventions

Compression stocking 15-20mmHgDEVICE

Compression stocking with 15-20mmHg of compression

Compression stocking 20-30mmHgDEVICE

Compression stocking with 20-30mmHg of compression

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Recently healed venous insufficiency ulcerations * History of venous insufficiency * Patient from UH Richmond Wound Care Center (recently discharged/healed venous ulcerations) Exclusion Criteria: * Children * Patients with diagnosed arterial insufficiency or ABI less than 0.5 * Patients that are diagnosed with Congestive Heart Failure and not cardiac cleared * Patients with paralysis or incapacitated physically or mentally (due to inability to apply compression stockings)

Locations (1)

Richmond Medical Center (University Hospitals of Cleveland)

Richmond Heights, Ohio, United States

Outcomes

Primary Outcomes

Compliance of Compression Therapy

Patients will be assessed for compliance of compression therapy at the following intervals (1 month, 3 months, 6 months, 9 months, and 12 months) -- this will be accomplished via patient questionnaire/interview at scheduled appointments at each stated interval.

Time frame: 12 months

Secondary Outcomes

Ulceration recurrence

We will evaluate if venous ulcerations have recurred with compression therapy over the course of 12 months. The patient will be seen/evaluated at appointments scheduled at 1 month, 3 months, 6 months, 9 months and 12 months. At each visit, the patient will be evaluated for recurrence of ulcerations. If ulceration recurs, then the patient will be removed from the study and be eligible for treatment of ulcerations.

Time frame: 12 months

Data from ClinicalTrials.gov

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