Study of Individualized Wound Prevention Instruction to Prevent Venous Ulcer Development

Phase 1

Terminated

• Conditions: Varicose Ulcer
• Interventions: Behavioral: Aftercare summary

• Registration Number: NCT00727701
• Lead Sponsor: US Department of Veterans Affairs

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.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-30
• Study First Submitted QC: 2008-07-30
• Study First Posted: 2008-08-04
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-25
• Last Update Posted: 2015-06-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Aftercare summary	Will receive usual wound prevention care, aftercare summaries, and regular surveillance.

Primary Outcome Measures

Name	Time	Method
Ulcer-free survival period	Telephone call every 2 weeks, on-site visit quarterly (depends on study arm)

Secondary Outcome Measures

Name	Time	Method
Adherence with self-management goals	Telephone call every 2 weeks, on-site visit at 2.5 and 5 months.
Change in quality of life	Telephone call every 2 weeks, on-site visit at 2.5 and 5 months.
Change in satisfaction with care	Telephone call every 2 weeks, on-site visit at 2.5 and 5 months.

Trial Locations

Locations (1)

VA Puget Sound Health Care System, Seattle; 🇺🇸 Seattle, Washington, United States