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Study of Individualized Wound Prevention Instruction to Prevent Venous Ulcer Development

Primary Purpose

Varicose Ulcer

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Aftercare summary

About this trial

This is an interventional prevention trial for Varicose Ulcer focused on measuring varicose ulcer, veteran, recurrence, aftercare

Eligibility Criteria

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

Inclusion Criteria:

Confirmed venous ulcer (ICD-9: 454.0, 454.2, 459.11, 459.13, 459.31, 459.33);
Documented healing of all lower extremity ulcers;
Ankle-brachial index (ABI) > 0.8 to rule out arterial insufficiency

Exclusion Criteria:

Unwilling or unable to sign informed consent;
No plans to seek care at VA Puget Sound within 6 months;
Limbs with ulcers or threatened viability

Sites / Locations

VA Puget Sound Health Care System, Seattle

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

Arm Description

Will receive usual wound prevention care, aftercare summaries, and regular surveillance.

Will receive usual wound prevention and surveillance only.

Will receive usual wound prevention only.

Outcomes

Primary Outcome Measures

Ulcer-free survival period

Secondary Outcome Measures

Change in quality of life

Change in satisfaction with care

Adherence with self-management goals

Full Information

NCT ID

NCT00727701

First Posted

July 30, 2008

Last Updated

June 25, 2015

Sponsor

US Department of Veterans Affairs

1. Study Identification

Unique Protocol Identification Number

NCT00727701

Brief Title

Study of Individualized Wound Prevention Instruction to Prevent Venous Ulcer Development

Official Title

Does Use of a Wound After-care Summary for Patients With a History of Venous Ulcers Lower Recurrence Rate?

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Terminated

Why Stopped

Study delayed for over a year by research shutdown at Seattle VA and other issues. Study designer moved to Ann Arbor in the interim, so the study was closed.

Study Start Date

July 2008 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine whether individualized wound prevention instructions will lengthen the ulcer-free period in veterans with recently healed venous ulcers.

Detailed Description

Venous ulcer disease is the most common form of lower extremity ulcer, and treatment requires months to years of costly intervention. Preventing venous ulcers from recurring is ideal, however, healing time is variable, possibly due to inadequate patient/clinician communication and surveillance. An aftercare summary is a detailed set of self-care instructions designed to help patients understand and influence preventative factors under their control. They have successfully been used in patients with cardiac disease and are currently being tested to help prevent diabetic foot ulcers. We propose the use of an aftercare summary to help prevent ulcer recurrence in veterans with recently healed venous ulcers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Varicose Ulcer

Keywords

varicose ulcer, veteran, recurrence, aftercare

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Will receive usual wound prevention care, aftercare summaries, and regular surveillance.

Arm Title

Arm Type

No Intervention

Arm Description

Will receive usual wound prevention and surveillance only.

Arm Title

Arm Type

No Intervention

Arm Description

Will receive usual wound prevention only.

Intervention Type

Behavioral

Intervention Name(s)

Aftercare summary

Intervention Description

A personalized, targeted set of self-care instructions for venous ulcer prevention, including a graphical depiction of patient adherence to self-care goals.

Primary Outcome Measure Information:

Title

Ulcer-free survival period

Time Frame

Telephone call every 2 weeks, on-site visit quarterly (depends on study arm)

Secondary Outcome Measure Information:

Title

Change in quality of life

Time Frame

Telephone call every 2 weeks, on-site visit at 2.5 and 5 months.

Title

Change in satisfaction with care

Time Frame

Telephone call every 2 weeks, on-site visit at 2.5 and 5 months.

Title

Adherence with self-management goals

Time Frame

Telephone call every 2 weeks, on-site visit at 2.5 and 5 months.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Confirmed venous ulcer (ICD-9: 454.0, 454.2, 459.11, 459.13, 459.31, 459.33); Documented healing of all lower extremity ulcers; Ankle-brachial index (ABI) > 0.8 to rule out arterial insufficiency Exclusion Criteria: Unwilling or unable to sign informed consent; No plans to seek care at VA Puget Sound within 6 months; Limbs with ulcers or threatened viability

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gayle E. Reiber, MPH PhD

Organizational Affiliation

VA Puget Sound Health Care System, Seattle

Official's Role

Principal Investigator

Facility Information:

Facility Name

VA Puget Sound Health Care System, Seattle

City

Seattle

State/Province

Washington

ZIP/Postal Code

98101

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Study of Individualized Wound Prevention Instruction to Prevent Venous Ulcer Development

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