Compliance of Compression Therapy in Healed Venous Ulcerations

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by University Hospital Case Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
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
  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 Hospital Case Medical Center:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Hospital Case Medical Center
Investigators
Principal Investigator: Nicole E Allen-Wilson, DPM University Hospital Case Medical Center
  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 Hospital Case Medical Center:
Venous insufficiency
Venous stasis ulcerations
Compression stockings
Compression stocking compliance

Additional relevant MeSH terms:
Ulcer
Varicose Ulcer
Venous Insufficiency
Cardiovascular Diseases
Leg Ulcer
Pathologic Processes
Skin Diseases
Skin Ulcer
Varicose Veins
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014