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Venous Leg Ulcer and Lymphedema Registry (VLULR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02813187
Recruitment Status : Enrolling by invitation
First Posted : June 24, 2016
Last Update Posted : April 25, 2018
Sponsor:
Information provided by (Responsible Party):
U.S. Wound Registry

Brief 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 Meaningful Use of an EHR.

Condition or disease Intervention/treatment
Venous Stasis Ulcer Quality of Patient Care Biological: cellular and tissue based therapy Procedure: debridement Procedure: advanced wound therapy Dietary Supplement: Nutritional screening

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: A Real World, Observational Registry of Venous Leg Ulcers and Quality of Care in Clinical Practice
Actual Study Start Date : May 2016
Estimated Primary Completion Date : May 2025
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine



Intervention Details:
  • Biological: cellular and tissue based therapy
    Other Names:
    • Apligraf
    • Dermagraft
    • Theraskin
    • Epifix
    • Dermapure
    • Grafix
    • Talymed
  • Procedure: debridement
  • Procedure: advanced wound therapy
  • Dietary Supplement: Nutritional screening


Primary Outcome Measures :
  1. Wound Healing [ Time Frame: 12 months ]
    wound closure


Secondary Outcome Measures :
  1. Weeks of Therapy [ Time Frame: 12 months ]
    days from initial visit to discharge

  2. Adverse events during therapy [ Time Frame: 12 months ]
    hospitalization, cellulitis, amputation

  3. Patient Reported Outcome [ Time Frame: 12 months ]
    using patient reported outcome quality measure

  4. Venous Insufficiency [ Time Frame: 12 months ]
    secondary lymphedema and its relationship to venous insufficiency



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Prospectively followed venous leg ulcers in the practice of clinicians submitting data to the registry
Criteria

Inclusion Criteria:

  • All patients with venous leg ulcers seen by the practitioner.

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02813187


Locations
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United States, Texas
CHI St. Luke's The Woodlands
The Woodlands, Texas, United States, 77384
Sponsors and Collaborators
U.S. Wound Registry
Additional Information:

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Responsible Party: U.S. Wound Registry
ClinicalTrials.gov Identifier: NCT02813187    
Other Study ID Numbers: CDR006
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: April 25, 2018
Last Verified: April 2018
Keywords provided by U.S. Wound Registry:
venous leg ulcer
venous
QCDR
quality measure
wound
Outcome
Lymphedema
Additional relevant MeSH terms:
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Varicose Ulcer
Leg Ulcer
Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases
Varicose Veins
Vascular Diseases
Cardiovascular Diseases