Study of Individualized Wound Prevention Instruction to Prevent Venous Ulcer Development

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00727701

Enrollment

Registered

2008-08-04

Start date

2008-07-31

Completion date

2009-06-30

Last updated

2015-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Varicose Ulcer

Keywords

varicose ulcer, veteran, recurrence, aftercare

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.

Interventions

BEHAVIORALAftercare summary

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.
Adherence with self-management goals	Telephone call every 2 weeks, on-site visit at 2.5 and 5 months.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026