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 Hospitals of Cleveland.
Recruitment status was  Not yet recruiting
Information provided by (Responsible Party):
Nicole Allen-Wilson, DPM, University Hospitals of Cleveland Identifier:
First received: August 31, 2012
Last updated: September 4, 2012
Last verified: September 2012

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts 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)
  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 identifier: NCT01680809

Contact: Nicole E Allen-Wilson, DPM 4405856500
Contact: Barbara J Marshall, DPM 4405856500

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   
Sponsors and Collaborators
University Hospitals of Cleveland
Principal Investigator: Nicole E Allen-Wilson, DPM University Hospitals of Cleveland
  More Information

Responsible Party: Nicole Allen-Wilson, DPM, Resident Physician, Department of Podiatric Medicine, University Hospitals of Cleveland 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:
Venous Insufficiency
Varicose Ulcer
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Varicose Veins
Leg Ulcer
Skin Ulcer
Skin Diseases processed this record on September 18, 2014