Online Wound Electronic Medical Record (OWEMR) to Decrease Amputations in Diabetics

Study Overview
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Brief Summary
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The purpose of this study is to determine whether using the OWEMR as part of the standard of care for Diabetic Foot Ulcers reduces the rate of lower limb amputations and to quantify the relationship between glycemic control and the rate of amputation secondary to chronic foot ulcers in Type II Diabetes.

Detailed Description
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The Online Wound Electronic Medical Record (OWEMR) is a medical informatics tool that synthesizes data about complex wound problems from multiple sources and is innovative in its capability to performing these critical tasks: i) identification of the information needed to make treatment decisions at the point of care in real time ii) use intelligent search and report features to identify patients who require emergency interventions, and iii) provide evidence-based clinical decision support to clinicians. Use of the OWEMR includes digital photography as an objective measurement of wound healing rates.

Official Title
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Wound EMR to Decrease Limb Amputations in Persons With Diabetes

Conditions
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Wounds, Diabetes Complications, Diabetic Foot, Foot Ulcer

Intervention / Treatment
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* Other: Online Wound Electronic Medical Record


Participation Criteria
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Eligibility Criteria
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Signed informed Consent Type I or II diabetes* A break in the skin on the foot ≥ 0.5cm2 18 yrs of age or older Hemoglobin A1c value within the last 120 days No use of Investigational Agents /Devices on study or within 30 days prior to enrollment Subjects who will be locally available for the next 6 months

Ages Eligible for Study
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Minimum Age: 18 Years

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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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OWEMR<br>Medical centers will be randomized to use the Online Wound Electronic Medical Record to enhance care of patients with diabetic foot ulcers | Other: Online Wound Electronic Medical Record<br>* Online Wound Electronic Medical Record is a medical informatics tool that synthesizes data about complex wound problems from multiple sources and is innovative in its capability to performing these critical tasks: i) identification of the information needed to make treatment decisions at the point of care in real time ii) use intelligent search and report features to identify patients who require emergency interventions, and iii) provide evidence-based clinical decision support to clinicians<br>|
| No Intervention: Standard of Care<br>Medical/wound centers will be randomized to continue routine care of patients with diabetic foot ulcers | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower extremity amputation secondary to diabetic foot ulcer |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wounds, diabetic foot ulcer, amputation, diabetic foot, diabetes complications