| July 30, 2008 |
| July 23, 2009 |
| July 2008 |
| June 2009 (final data collection date for primary outcome measure) |
| Ulcer-free survival period [ Time Frame: Telephone call every 2 weeks, on-site visit quarterly (depends on study arm) ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00727701 on ClinicalTrials.gov Archive Site |
- Change in quality of life [ Time Frame: Telephone call every 2 weeks, on-site visit at 2.5 and 5 months. ] [ Designated as safety issue: No ]
- Change in satisfaction with care [ Time Frame: Telephone call every 2 weeks, on-site visit at 2.5 and 5 months. ] [ Designated as safety issue: No ]
- Adherence with self-management goals [ Time Frame: Telephone call every 2 weeks, on-site visit at 2.5 and 5 months. ] [ Designated as safety issue: No ]
|
| Same as current |
| |
| 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? |
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. |
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. |
| Phase I |
| Interventional |
| Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Varicose Ulcer |
| Behavioral: Aftercare summary |
- Experimental: Will receive usual wound prevention care, aftercare summaries, and regular surveillance.
- No Intervention: Will receive usual wound prevention and surveillance only.
- No Intervention: Will receive usual wound prevention only.
|
| |
| |
| Terminated |
| 0 |
| June 2009 |
| June 2009 (final data collection date for primary outcome measure) |
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
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00727701 |
| Reiber, Gayle - Principal Investigator, Department of Veterans Affairs |
| 08-246 |
| Department of Veterans Affairs |
|
| Principal Investigator: |
Gayle E. Reiber, MPH PhD |
VA Puget Sound Health Care System, Seattle |
|
|
| Department of Veterans Affairs |
| July 2009 |