The Diabetic Foot Ulcer Registry

NCT ID: NCT02813161

Last Updated: 2018-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2025-02-28

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.

Conditions

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Diabetic Foot Ulcer Outcome Quality of Patient Care

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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cellular and tissue based therapy

Intervention Type BIOLOGICAL

negative pressure wound therapy

Intervention Type DEVICE

debridement

Intervention Type PROCEDURE

advanced wound therapy

Intervention Type PROCEDURE

Nutritional screening

Intervention Type DIETARY_SUPPLEMENT

off-loading

Intervention Type DEVICE

Hyperbaric oxygen Therapy

Intervention Type DEVICE

Other Intervention Names

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Apligraf Dermagraft Theraskin Epifix Dermapure Graffix Talymed The VAC Pico SnAP TCC EZ-Cast Total Contact Casting CROW walker shoe modification

Eligibility Criteria

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Inclusion Criteria

* All patients with diabetic foot ulcers seen by the practitioner

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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APMA

UNKNOWN

Sponsor Role collaborator

U.S. Wound Registry

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHI St. Luke's The Woodlands

The Woodlands, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Monica Weir, MBA, CCRP

Role: CONTACT

(800) 603-7896

Caroline E Fife, MD

Role: CONTACT

(800) 603-7896

Facility Contacts

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Sherrill White Wolfe

Role: primary

936-266-2150

Other Identifiers

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CDR005

Identifier Type: -

Identifier Source: org_study_id

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