Compliance of Compression Therapy in Healed Venous Ulcerations

Not Applicable

Withdrawn

• Conditions: Venous Insufficiency
• Interventions: Device: Compression stocking 15-20mmHg; Device: Compression stocking 20-30mmHg

• Registration Number: NCT01680809
• Lead Sponsor: University Hospitals Cleveland Medical Center

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2012-08-31
• Study Start: 2012-09
• Study First Submitted QC: 2012-09-04
• Study First Posted: 2012-09-07
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-10
• Last Update Posted: 2022-05-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Compression stocking 15-20mmHg	Compression stocking 15-20mmHg	Compression stocking 15-20mmHg
Compression stocking 20-30mmHg	Compression stocking 20-30mmHg	Compression stocking 20-30mmHg

Primary Outcome Measures

Name	Time	Method
Compliance of Compression Therapy	12 months	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.

Secondary Outcome Measures

Name	Time	Method
Ulceration recurrence	12 months	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.

Trial Locations

Locations (1)

Richmond Medical Center (University Hospitals of Cleveland); 🇺🇸 Richmond Heights, Ohio, United States