Venous Leg Ulcer and Lymphedema Registry

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Venous Stasis Ulcer, Quality of Patient Care

Intervention / Treatment
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* Biological: cellular and tissue based therapy
* Procedure: debridement
* Procedure: advanced wound therapy
* Dietary Supplement: Nutritional screening


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients with venous leg ulcers seen by the practitioner. Exclusion Criteria: None
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: cellular and tissue based therapy|nan|
|Procedure: debridement|nan|
|Procedure: advanced wound therapy|nan|
|Dietary Supplement: Nutritional screening|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Healing | wound closure | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weeks of Therapy | days from initial visit to discharge | 12 months | 
| Adverse events during therapy | hospitalization, cellulitis, amputation | 12 months | 
| Patient Reported Outcome | using patient reported outcome quality measure | 12 months | 
| Venous Insufficiency | secondary lymphedema and its relationship to venous insufficiency | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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venous leg ulcer, venous, QCDR, quality measure, wound, Outcome, Lymphedema