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Compliance of Compression Therapy in Healed Venous Ulcerations

Primary Purpose

Venous Insufficiency

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Compression stocking 15-20mmHg
Compression stocking 20-30mmHg
Sponsored by
University Hospitals Cleveland Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Venous Insufficiency focused on measuring Venous insufficiency, Venous stasis ulcerations, Compression stockings, Compression stocking compliance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Richmond Medical Center (University Hospitals of Cleveland)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Compression stocking 15-20mmHg

Compression stocking 20-30mmHg

Arm Description

Compression stocking 15-20mmHg

Compression stocking 20-30mmHg

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 31, 2012
Last Updated
May 10, 2022
Sponsor
University Hospitals Cleveland Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01680809
Brief Title
Compliance of Compression Therapy in Healed Venous Ulcerations
Official Title
Compliance of Compression Therapy in Healed Venous Ulcerations
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Study never started
Study Start Date
September 2012 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
June 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospitals Cleveland Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Insufficiency
Keywords
Venous insufficiency, Venous stasis ulcerations, Compression stockings, Compression stocking compliance

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Compression stocking 15-20mmHg
Arm Type
Experimental
Arm Description
Compression stocking 15-20mmHg
Arm Title
Compression stocking 20-30mmHg
Arm Type
Experimental
Arm Description
Compression stocking 20-30mmHg
Intervention Type
Device
Intervention Name(s)
Compression stocking 15-20mmHg
Intervention Description
Compression stocking with 15-20mmHg of compression
Intervention Type
Device
Intervention Name(s)
Compression stocking 20-30mmHg
Intervention Description
Compression stocking with 20-30mmHg of compression
Primary Outcome Measure Information:
Title
Compliance of Compression Therapy
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Ulceration recurrence
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole E Allen-Wilson, DPM
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Richmond Medical Center (University Hospitals of Cleveland)
City
Richmond Heights
State/Province
Ohio
ZIP/Postal Code
44143
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19233601
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.
Results Reference
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PubMed Identifier
20678885
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. No abstract available.
Results Reference
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PubMed Identifier
10477642
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. doi: 10.1016/s0741-5214(99)70076-5.
Results Reference
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PubMed Identifier
17012004
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. doi: 10.1016/j.jvs.2006.05.051.
Results Reference
background
PubMed Identifier
15183623
Citation
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. doi: 10.1016/S0140-6736(04)16353-8.
Results Reference
background
Citation
Baranoski S, Ayello EA. Wound Care Essentials: Practice Principles, 3rd ed. Philadelphia, PA: Lippincott Williams and Wilkins, 2011. Print.
Results Reference
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Compliance of Compression Therapy in Healed Venous Ulcerations

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