The Diabetic Foot Ulcer Registry (DFUR)

U.S. Wound Registry

Status: Enrolling

Conditions: Diabetic Foot Ulcer Outcome; Quality of Patient Care

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

Study type: Observational

Funder types: Other

Identifiers

NCT02813161

CDR005

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 10,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients with diabetic foot ulcers seen by the practitioner

Exclusion criteria

• None