Compliance of Compression Therapy in Healed Venous Ulcerations
This study is not yet open for participant recruitment.
Verified September 2012 by University Hospitals of Cleveland
Sponsor:
University Hospitals of Cleveland
Information provided by (Responsible Party):
Nicole Allen-Wilson, DPM, University Hospitals of Cleveland
ClinicalTrials.gov Identifier:
NCT01680809
First received: August 31, 2012
Last updated: September 4, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Venous Insufficiency |
Device: Compression stocking 15-20mmHg Device: Compression stocking 20-30mmHg |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Compliance of Compression Therapy in Healed Venous Ulcerations |
Further study details as provided by University Hospitals of Cleveland:
Primary Outcome Measures:
- Compliance of Compression Therapy [ Time Frame: 12 months ] [ Designated as safety issue: No ]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:
- Ulceration recurrence [ Time Frame: 12 months ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 60 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Compression stocking 15-20mmHg
Compression stocking 15-20mmHg
|
Device: Compression stocking 15-20mmHg
Compression stocking with 15-20mmHg of compression
|
|
Experimental: Compression stocking 20-30mmHg
Compression stocking 20-30mmHg
|
Device: Compression stocking 20-30mmHg
Compression stocking with 20-30mmHg of compression
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01680809
Contacts
| Contact: Nicole E Allen-Wilson, DPM | 4405856500 | nicole.allenwilson@uhhospitals.org |
| Contact: Barbara J Marshall, DPM | 4405856500 | barbara.marshall@uhhospitals.org |
Locations
| United States, Ohio | |
| Richmond Medical Center (University Hospitals of Cleveland) | Not yet recruiting |
| Richmond Heights, Ohio, United States, 44143 | |
| Contact: Nicole E Allen-Wilson, DPM 440-585-6500 nicole.allenwilson@uhhospitals.org | |
Sponsors and Collaborators
University Hospitals of Cleveland
Investigators
| Principal Investigator: | Nicole E Allen-Wilson, DPM | University Hospitals of Cleveland |
More Information
Publications:
| Responsible Party: | Nicole Allen-Wilson, DPM, Resident Physician, Department of Podiatric Medicine, University Hospitals of Cleveland |
| ClinicalTrials.gov Identifier: | NCT01680809 History of Changes |
| Other Study ID Numbers: | CWCT-001 |
| Study First Received: | August 31, 2012 |
| Last Updated: | September 4, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University Hospitals of Cleveland:
|
Venous insufficiency Venous stasis ulcerations Compression stockings Compression stocking compliance |
Additional relevant MeSH terms:
|
Ulcer Varicose Ulcer Venous Insufficiency Pathologic Processes Varicose Veins |
Vascular Diseases Cardiovascular Diseases Leg Ulcer Skin Ulcer Skin Diseases |
ClinicalTrials.gov processed this record on May 23, 2013