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Venous Leg Ulcer and Lymphedema Registry — VLULR  

Venous Stasis Ulcer Clinical Trial

Official title:
A Real World, Observational Registry of Venous Leg Ulcers and Quality of Care in Clinical Practice

Clinical 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 Meaningful Use of an EHR.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02813187
Study type Observational [Patient Registry]
Source U.S. Wound Registry
Contact
Status Enrolling by invitation
Phase
Start date May 2016
Completion date June 2025
View Details
See also
  Status Clinical Trial Phase
Terminated NCT00534937 - Flexitouch Compression System for Venous Stasis Ulcer Phase 4
Terminated NCT01853384 - Safety and Efficacy Trial of HP802-247 in the Treatment of Chronic Venous Leg Ulcers Phase 3
Completed NCT03881267 - SkinTE® in the Treatment of Venous Leg Wounds N/A
Terminated NCT01376050 - Efficacy Study of the Application of Low Level Laser Light to Treat Venous Stasis Ulcers N/A
Terminated NCT01612806 - A Multi-center, Prospective, Randomized Study With PriMatrix and PriMatrix Ag for the Treatment of Venous Leg Ulcers N/A
Completed NCT00900029 - Safety Follow-Up to HP 802-247-09-015 N/A
Completed NCT02626156 - Cooling Leg and Foot Ulcer Skin Post Healing to Prevent Ulcer Recurrence Phase 2
Recruiting NCT02322554 - Cellular and Tissue Based Therapy Registry
Recruiting NCT02467998 - Negative Pressure Wound Therapy Registry
Recruiting NCT04647240 - Dermacyte® Amniotic Wound Care Liquid for the Treatment of Non-Healing Venous Stasis Ulcers Phase 2
Completed NCT02395302 - Evaluation of a Dual Action Pneumatic Compression System: Tolerance and Comfort in Patients With Venous Leg Ulcers N/A
Completed NCT00270946 - Evaluation of Bilayered Cellular Matrix (OrCel) for the Treatment of Venous Ulcers N/A