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Clinical Trials/NCT01680809
NCT01680809WithdrawnNot Applicable

Compliance of Compression Therapy in Healed Venous Ulcerations

University Hospitals Cleveland Medical Center1 site in 1 countryStarted: September 1, 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Locations
1
Primary Endpoint
Compliance of Compression Therapy

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
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

  • •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)

Arms & Interventions

Compression stocking 15-20mmHg

Experimental

Compression stocking 15-20mmHg

Intervention: Compression stocking 15-20mmHg (Device)

Compression stocking 20-30mmHg

Experimental

Compression stocking 20-30mmHg

Intervention: Compression stocking 20-30mmHg (Device)

Outcomes

Primary Outcomes

Compliance of Compression Therapy

Time Frame: 12 months

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 Outcomes

  • Ulceration recurrence(12 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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