Study of Individualized Wound Prevention Instruction to Prevent Venous Ulcer Development

Varicose Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00727701
• Other study ID #: 08-246
• Status: Terminated
• Phase: Phase 1
• First received: July 30, 2008
• Last updated: June 25, 2015
• Start date: July 2008
• Est. completion date: June 2009

Study information

• Verified date: June 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 72
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Ulcer
• Varicose Ulcer

Intervention

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

Locations

Country	Name	City	State
United States	VA Puget Sound Health Care System, Seattle	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ulcer-free survival period		Telephone call every 2 weeks, on-site visit quarterly (depends on study arm)	No
Secondary	Change in quality of life		Telephone call every 2 weeks, on-site visit at 2.5 and 5 months.	No
Secondary	Change in satisfaction with care		Telephone call every 2 weeks, on-site visit at 2.5 and 5 months.	No
Secondary	Adherence with self-management goals		Telephone call every 2 weeks, on-site visit at 2.5 and 5 months.	No