The Diabetic Foot Ulcer Registry

Study Overview
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Brief Summary
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This is an observational, longitudinal real world registry of diabetic foot 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 diabetic foot 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 benchmarking 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 Diabetic Foot Ulcers and Quality of Care in Clinical Practice

Conditions
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Diabetic Foot Ulcer Outcome, Quality of Patient Care

Intervention / Treatment
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* Biological: cellular and tissue based therapy
* Device: negative pressure wound therapy
* Procedure: debridement
* Procedure: advanced wound therapy
* Dietary Supplement: Nutritional screening
* Device: off-loading
* Device: Hyperbaric oxygen Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients with diabetic foot 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|
|Device: negative pressure wound therapy|nan|
|Procedure: debridement|nan|
|Procedure: advanced wound therapy|nan|
|Dietary Supplement: Nutritional screening|nan|
|Device: off-loading|nan|
|Device: Hyperbaric oxygen Therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing | wound closure | 6 months | 
| major amputation | above the knee, below the knee | 6 months | 
| minor amputation with preservation of ambulation | toe amputation, transmetatarsal | 6 months | 
| Death | death without wound closure | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Quality of life | W-QoL score | 12 weeks | 
| Patient Reported Outcome | using patient reported outcome quality measure | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetic foot ulcer, diabetes, arterial disease, neuropathy, amputation, QCDR, quality measure, wound