Venous Insufficiency
Conditions
Keywords
Venous insufficiency, Venous stasis ulcerations, Compression stockings, Compression stocking compliance
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.
Interventions
DEVICECompression stocking 15-20mmHg
Compression stocking with 15-20mmHg of compression
DEVICECompression stocking 20-30mmHg
Compression stocking with 20-30mmHg of compression
Sponsors
University Hospitals Cleveland Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed