Varicose UlcerPhase 1NCT00727701
Study of Individualized Wound Prevention Instruction to Prevent Venous Ulcer Development
A Phase 1 study testing Aftercare summary in people with Varicose Ulcer, run by US Department of Veterans Affairs at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Varicose Ulcer
- What is being tested?
- Aftercare summary
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Jun 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System, Seattle
Seattle, Washington, 98101
About this study
Official title: 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.
Read the 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.
- Conditions
- Varicose Ulcer
- Being tested
- Aftercare summary
- Keywords
- varicose ulcer, veteran, recurrence, aftercare
- Medical subject headings
- Varicose Ulcer, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aftercare summaryBehavioural
A personalized, targeted set of self-care instructions for venous ulcer prevention, including a graphical depiction of patient adherence to self-care goals.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Will receive usual wound prevention care, aftercare summaries, and regular surveillance. Receives: Behavioral: Aftercare summary |
| 2 | No intervention | Will receive usual wound prevention and surveillance only. |
| 3 | No intervention | Will receive usual wound prevention only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ulcer-free survival period
Measured: Telephone call every 2 weeks, on-site visit quarterly (depends on study arm)
Secondary outcomes (3)
Change in quality of life
Measured: Telephone call every 2 weeks, on-site visit at 2.5 and 5 months.
Change in satisfaction with care
Measured: Telephone call every 2 weeks, on-site visit at 2.5 and 5 months.
Adherence with self-management goals
Measured: Telephone call every 2 weeks, on-site visit at 2.5 and 5 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionJun 2009
- Study completionJun 2009
Why it stopped: Study delayed for over a year by research shutdown at Seattle VA and other issues. Study designer moved to Ann Arbor in the interim, so the study was closed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicose UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- Gayle E. Reiber, MPH PhD, Principal investigator, VA Puget Sound Health Care System, Seattle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00727701
- Sponsor's protocol ID
- 08-246
- Status last verified
- Jun 2015
- First submitted
- 30 Jul 2008
- Last updated
- 26 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Use of a Wound After-care Summary for Patients With a History of Venous Ulcers Lower Recurrence Rate?
- ClinicalTrials.gov ID
- NCT00727701
- Acronym / sponsor ID
- 08-246
- Conditions
- Varicose Ulcer
- Keywords
- varicose ulcer, veteran, recurrence, aftercare
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study delayed for over a year by research shutdown at Seattle VA and other issues. Study designer moved to Ann Arbor in the interim, so the study was closed.
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jul 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 4 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Aftercare summaryWill receive usual wound prevention care, aftercare summaries, and regular surveillance. |
| 2 | No intervention | –Will receive usual wound prevention and surveillance only. |
| 3 | No intervention | –Will receive usual wound prevention only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aftercare summaryA personalized, targeted set of self-care instructions for venous ulcer prevention, including a graphical depiction of patient adherence to self-care goals. | Behavioural | 1 |
Primary outcome
Ulcer-free survival period
Time frame: Telephone call every 2 weeks, on-site visit quarterly (depends on study arm)
3 secondary outcomes
Change in quality of life
Time frame: Telephone call every 2 weeks, on-site visit at 2.5 and 5 months.
Change in satisfaction with care
Time frame: Telephone call every 2 weeks, on-site visit at 2.5 and 5 months.
Adherence with self-management goals
Time frame: Telephone call every 2 weeks, on-site visit at 2.5 and 5 months.
Results and safety
The study was stopped early (reason given: Study delayed for over a year by research shutdown at Seattle VA and other issues. Study designer moved to Ann Arbor in the interim, so the study was closed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gayle E. Reiber, MPH PhD principal investigator
VA Puget Sound Health Care System, Seattle
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Aftercare summary in people with Varicose Ulcer, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study delayed for over a year by research shutdown at Seattle VA and other issues. Study designer moved to Ann Arbor in the interim, so the study was closed.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ulcer-free survival period (time frame: Telephone call every 2 weeks, on-site visit quarterly (depends on study arm)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2015; AzTrials last refreshed its copy on 7 Nov 2026.