NCT01680809

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2012

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 7, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

May 17, 2022

Status Verified

May 1, 2022

Enrollment Period

1.7 years

First QC Date

August 31, 2012

Last Update Submit

May 10, 2022

Conditions

Venous Insufficiency

Keywords

Venous insufficiencyVenous stasis ulcerationsCompression stockingsCompression stocking compliance

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Ulceration recurrence

    12 months

Study Arms (2)

Compression stocking 15-20mmHg

EXPERIMENTAL

Compression stocking 15-20mmHg

Device: Compression stocking 15-20mmHg

Compression stocking 20-30mmHg

EXPERIMENTAL

Compression stocking 20-30mmHg

Device: Compression stocking 20-30mmHg

Interventions

Compression stocking 15-20mmHgDEVICE

Compression stocking with 15-20mmHg of compression

Compression stocking 15-20mmHg
Compression stocking 20-30mmHgDEVICE

Compression stocking with 20-30mmHg of compression

Compression stocking 20-30mmHg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Recently healed venous insufficiency ulcerations
  • History of venous insufficiency
  • Patient from UH Richmond Wound Care Center (recently discharged/healed venous ulcerations)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Richmond Medical Center (University Hospitals of Cleveland)

Richmond Heights, Ohio, 44143, United States

Location

Related Publications (6)

  • 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.

    PMID: 19233601BACKGROUND

  • 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.

    PMID: 20678885BACKGROUND

  • 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.

    PMID: 10477642BACKGROUND

  • 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.

    PMID: 17012004BACKGROUND

  • 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.

    PMID: 15183623BACKGROUND

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

    BACKGROUND

MeSH Terms

Conditions

Venous Insufficiency

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Nicole E Allen-Wilson, DPM

    University Hospitals Cleveland Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2012

First Posted

September 7, 2012

Study Start

September 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

May 17, 2022

Record last verified: 2022-05

Locations

US(1)