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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.
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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cellular and tissue based therapy | Biological |
| ||
| debridement | Procedure | |||
| advanced wound therapy | Procedure | |||
| Nutritional screening | Dietary Supplement |
| Measure | Description | Time Frame |
|---|---|---|
| Wound Healing | wound closure | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Weeks of Therapy | days from initial visit to discharge | 12 months |
| Adverse events during therapy | hospitalization, cellulitis, amputation |
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Inclusion Criteria:
Exclusion Criteria:
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Prospectively followed venous leg ulcers in the practice of clinicians submitting data to the registry
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHI St. Luke's The Woodlands | The Woodlands | Texas | 77384 | United States |
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| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| D014947 | Wounds and Injuries |
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
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| ID | Term |
|---|---|
| D002452 | Cell Count |
| C117898 | Apligraf |
| C512800 | TransCyte |
| D003646 | Debridement |
| ID | Term |
|---|---|
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| 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 |
| D012883 |
| Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008919 | Investigative Techniques |
| D002468 | Cell Physiological Phenomena |
| D013514 | Surgical Procedures, Operative |