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Study of Individualized Wound Prevention Instruction to Prevent Venous Ulcer Development

US Department of Veterans Affairs (VA) logo

US Department of Veterans Affairs (VA)

Status and phase

Terminated
Phase 1

Conditions

Varicose Ulcer

Treatments

Behavioral: Aftercare summary

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

72 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

72 participants in 3 patient groups

1
Experimental group
Description:
Will receive usual wound prevention care, aftercare summaries, and regular surveillance.
Treatment:
Behavioral: Aftercare summary
2
No Intervention group
Description:
Will receive usual wound prevention and surveillance only.
3
No Intervention group
Description:
Will receive usual wound prevention only.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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