Compliance of Compression Therapy in Healed Venous Ulcerations

Study Overview
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Brief Summary
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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
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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.

Official Title
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Compliance of Compression Therapy in Healed Venous Ulcerations

Conditions
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Venous Insufficiency

Intervention / Treatment
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* Device: Compression stocking 15-20mmHg
* Device: Compression stocking 20-30mmHg


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Compression stocking 15-20mmHg<br>Compression stocking 15-20mmHg | Device: Compression stocking 15-20mmHg<br>* Compression stocking with 15-20mmHg of compression<br>|
| Experimental: Compression stocking 20-30mmHg<br>Compression stocking 20-30mmHg | Device: Compression stocking 20-30mmHg<br>* Compression stocking with 20-30mmHg of compression<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Venous insufficiency, Venous stasis ulcerations, Compression stockings, Compression stocking compliance