Compliance of Compression Therapy in Healed Venous Ulcerations

Venous Insufficiency Clinical Trial

Official title:

Compliance of Compression Therapy in Healed Venous Ulcerations

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01680809
• Other study ID #: CWCT-001
• Status: Withdrawn
• Phase: N/A
• Start date: September 2012
• Est. completion date: June 2014

Study information

• Verified date: May 2022
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Ulcer
• Varicose Ulcer
• Venous Insufficiency

Intervention

Device:
• Compression stocking 15-20mmHg
Compression stocking with 15-20mmHg of compression
• Compression stocking 20-30mmHg
Compression stocking with 20-30mmHg of compression

Locations

Country	Name	City	State
United States	Richmond Medical Center (University Hospitals of Cleveland)	Richmond Heights	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (6)

Baranoski S, Ayello EA. Wound Care Essentials: Practice Principles, 3rd ed. Philadelphia, PA: Lippincott Williams and Wilkins, 2011. Print.

Barwell JR, Davies CE, Deacon J, Harvey K, Minor J, Sassano A, Taylor M, Usher J, Wakely C, Earnshaw JJ, Heather BP, Mitchell DC, Whyman MR, Poskitt KR. Comparison of surgery and compression with compression alone in chronic venous ulceration (ESCHAR study): randomised controlled trial. Lancet. 2004 Jun 5;363(9424):1854-9. — View Citation

Gillespie DL; Writing Group III of the Pacific Vascular Symposium 6, Kistner B, Glass C, Bailey B, Chopra A, Ennis B, Marston B, Masuda E, Moneta G, Nelzen O, Raffetto J, Raju S, Vedantham S, Wright D, Falanga V. Venous ulcer diagnosis, treatment, and prevention of recurrences. J Vasc Surg. 2010 Nov;52(5 Suppl):8S-14S. doi: 10.1016/j.jvs.2010.05.068. Epub 2010 Aug 3. Review. — View Citation

Marston WA, Carlin RE, Passman MA, Farber MA, Keagy BA. Healing rates and cost efficacy of outpatient compression treatment for leg ulcers associated with venous insufficiency. J Vasc Surg. 1999 Sep;30(3):491-8. — View Citation

Milic DJ, Zivic SS, Bogdanovic DC, Karanovic ND, Golubovic ZV. Risk factors related to the failure of venous leg ulcers to heal with compression treatment. J Vasc Surg. 2009 May;49(5):1242-7. doi: 10.1016/j.jvs.2008.11.069. Epub 2009 Feb 23. — View Citation

Nelson EA, Harper DR, Prescott RJ, Gibson B, Brown D, Ruckley CV. Prevention of recurrence of venous ulceration: randomized controlled trial of class 2 and class 3 elastic compression. J Vasc Surg. 2006 Oct;44(4):803-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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