NCT00727701

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 4, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

June 26, 2015

Status Verified

June 1, 2015

Enrollment Period

11 months

First QC Date

July 30, 2008

Last Update Submit

June 25, 2015

Conditions

Varicose Ulcer

Keywords

varicose ulcerveteranrecurrenceaftercare

Outcome Measures

Primary Outcomes (1)

  • Ulcer-free survival period

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

Secondary Outcomes (3)

  • 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.

Study Arms (3)

1

EXPERIMENTAL

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

Behavioral: Aftercare summary

2

NO INTERVENTION

Will receive usual wound prevention and surveillance only.

3

NO INTERVENTION

Will receive usual wound prevention only.

Interventions

Aftercare summaryBEHAVIORAL

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

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Puget Sound Health Care System, Seattle

Seattle, Washington, 98101, United States

Location

MeSH Terms

Conditions

Varicose UlcerRecurrence

Condition Hierarchy (Ancestors)

Varicose VeinsVascular DiseasesCardiovascular DiseasesLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gayle E. Reiber, MPH PhD

    VA Puget Sound Health Care System, Seattle

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

July 30, 2008

First Posted

August 4, 2008

Study Start

July 1, 2008

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

June 26, 2015

Record last verified: 2015-06

Locations

US(1)