Venous Stasis UlcerVLULRNCT02813187
Venous Leg Ulcer and Lymphedema Registry
An observational study of Venous Stasis Ulcer and Quality of Patient Care, run by U.S. Wound Registry at 1 site in United States.
Trial summary
This is an observational, longitudinal real world registry of venous leg ulcers created from electronic health record data obtained in the course of clinical care. Data from certified electronic health records transmit data as part of the requirement to share data with a specialty registry under Objective 10 of… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Venous Stasis Ulcer, Quality of Patient Care
- What is being tested?
- cellular and tissue based therapy, debridement and advanced wound therapy
- Type of treatment
- Surgery or procedure
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Jun 2025
- How long will I take part?
- 1 Month
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Prospectively followed venous leg ulcers in the practice of clinicians submitting data to the registry
Who may be able to join
- All patients with venous leg ulcers seen by the practitioner.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
CHI St. Luke's The Woodlands
The Woodlands, Texas, 77384
About this study
Official title: A Real World, Observational Registry of Venous Leg Ulcers and Quality of Care in Clinical Practice
This is an observational, longitudinal real world registry of venous leg ulcers created from electronic health record data obtained in the course of clinical care. Data from certified electronic health records transmit data as part of the requirement to share data with a specialty registry under Objective 10 of Meaningful Use of an EHR.
Read the detailed description
This is an observational, longitudinal real world registry of venous leg ulcers created from electronic health record data obtained in the course of clinical care. Data from certified electronic health records transmit data as part of the requirement to share data with a specialty registry under Objective 10 of Meaningful Use of an EHR. No secondary data entry are required and all data are obtained via structured language from data entered in the EHR. Data from quality measures designed as electronic clinical quality measures (eCQMs) standardize the quality of care provided to patients and their clinical outcomes which are risk stratified using the Wound Healing Index (WHI). The eCQMs enable standardized data collection and the ability to transmit data electronically obviates the possibility of transcription errors. National bench marking is possible since data are available from thousands of participants across the USA. While an independent IRB oversees this project, the data are collected for the purpose of measuring and improving the quality of care delivered to diabetic patients with foot ulcers and understanding their outcomes in relation to level of risk. Quality performance is reported as part of PQRS. These functions are exempt from the requirements of informed consent.
- Conditions
- Venous Stasis Ulcer, Quality of Patient Care
- Being tested
- cellular and tissue based therapy, debridement, advanced wound therapy, Nutritional screening
- Keywords
- venous leg ulcer, venous, QCDR, quality measure, wound, Outcome, Lymphedema
- Medical subject headings
- Varicose Ulcer, Wounds and Injuries, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cellular and tissue based therapyBiological
Also called Apligraf, Dermagraft, Theraskin, Epifix
debridementProcedure or surgery
advanced wound therapyProcedure or surgery
Nutritional screeningDietary supplement
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Healing
wound closure
Measured: 12 months
Secondary outcomes (4)
Weeks of Therapy
days from initial visit to discharge
Measured: 12 months
Adverse events during therapy
hospitalization, cellulitis, amputation
Measured: 12 months
Patient Reported Outcome
using patient reported outcome quality measure
Measured: 12 months
Venous Insufficiency
secondary lymphedema and its relationship to venous insufficiency
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Stasis 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- U.S. Wound Registry
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02813187
- Sponsor's protocol ID
- CDR006
- Acronym
- VLULR
- Status last verified
- Apr 2018
- First submitted
- 10 Jun 2016
- Last updated
- 25 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real World, Observational Registry of Venous Leg Ulcers and Quality of Care in Clinical Practice
- ClinicalTrials.gov ID
- NCT02813187
- Acronym / sponsor ID
- VLULR / CDR006
- Conditions
- Venous Stasis Ulcer, Quality of Patient Care
- Keywords
- venous leg ulcer, venous, QCDR, quality measure, wound, Outcome, Lymphedema
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- U.S. Wound RegistryUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 24 Jun 2016 (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.
This is an observational, longitudinal real world registry of venous leg ulcers created from electronic health record data obtained in the course of clinical care. Data from certified electronic health records transmit data as part of the requirement to share data with a specialty registry under Objective 10 of Meaningful Use of an EHR.
Detailed description
This is an observational, longitudinal real world registry of venous leg ulcers created from electronic health record data obtained in the course of clinical care. Data from certified electronic health records transmit data as part of the requirement to share data with a specialty registry under Objective 10 of Meaningful Use of an EHR. No secondary data entry are required and all data are obtained via structured language from data entered in the EHR. Data from quality measures designed as electronic clinical quality measures (eCQMs) standardize the quality of care provided to patients and their clinical outcomes which are risk stratified using the Wound Healing Index (WHI). The eCQMs enable standardized data collection and the ability to transmit data electronically obviates the possibility of transcription errors. National bench marking is possible since data are available from thousands of participants across the USA. While an independent IRB oversees this project, the data are collected for the purpose of measuring and improving the quality of care delivered to diabetic patients with foot ulcers and understanding their outcomes in relation to level of risk. Quality performance is reported as part of PQRS. These functions are exempt from the requirements of informed consent.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Prospectively followed venous leg ulcers in the practice of clinicians submitting data to the registry
Key inclusion criteria (1 listed)
- All patients with venous leg ulcers seen by the practitioner.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| cellular and tissue based therapyAlso: Apligraf, Dermagraft, Theraskin, Epifix | Biological | – |
| debridement | Procedure or surgery | – |
| advanced wound therapy | Procedure or surgery | – |
| Nutritional screening | Dietary supplement | – |
Primary outcome
Wound Healing
Time frame: 12 months
wound closure
4 secondary outcomes
Weeks of Therapy
Time frame: 12 months
Adverse events during therapy
Time frame: 12 months
Patient Reported Outcome
Time frame: 12 months
Venous Insufficiency
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Stasis Ulcer and Quality of Patient Care, run by U.S. Wound Registry 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 25 Apr 2018. 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.
Are results available for this study?
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?
Wound Healing (time frame: 12 months). 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 25 Apr 2018.