Venous Leg Ulcer and Lymphedema Registry

NCT ID: NCT02813187

Last Updated: 2018-04-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 10000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2025-06-30

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.

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

cellular and tissue based therapy

Intervention Type: BIOLOGICAL

debridement

Intervention Type: PROCEDURE

advanced wound therapy

Intervention Type: PROCEDURE

Nutritional screening

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Apligraf; Dermagraft; Theraskin; Epifix; Dermapure; Grafix; Talymed

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

U.S. Wound Registry

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHI St. Luke's The Woodlands

The Woodlands, Texas, United States

Countries

United States

Other Identifiers

CDR006

Identifier Type: -

Identifier Source: org_study_id