Compliance of Compression Therapy in Healed Venous Ulcerations

NCT ID: NCT01680809

Last Updated: 2022-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-06-30

Brief Summary

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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

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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.

Conditions

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Venous Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Compression stocking 15-20mmHg

Compression stocking 15-20mmHg

Group Type EXPERIMENTAL

Compression stocking 15-20mmHg

Intervention Type DEVICE

Compression stocking with 15-20mmHg of compression

Compression stocking 20-30mmHg

Compression stocking 20-30mmHg

Group Type EXPERIMENTAL

Compression stocking 20-30mmHg

Intervention Type DEVICE

Compression stocking with 20-30mmHg of compression

Interventions

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Compression stocking 15-20mmHg

Compression stocking with 15-20mmHg of compression

Intervention Type DEVICE

Compression stocking 20-30mmHg

Compression stocking with 20-30mmHg of compression

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospitals Cleveland Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicole E Allen-Wilson, DPM

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

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Richmond Medical Center (University Hospitals of Cleveland)

Richmond Heights, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 19233601 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20678885 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10477642 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17012004 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15183623 (View on PubMed)

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

Reference Type BACKGROUND

Other Identifiers

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CWCT-001

Identifier Type: -

Identifier Source: org_study_id

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