The Diabetic Foot Ulcer Registry

Quality of Patient Care Clinical Trial

— DFUR  

Official title:

A Real World, Observational Registry of Diabetic Foot Ulcers and Quality of Care in Clinical Practice

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02813161
• Other study ID #: CDR005
• Status: Recruiting
• Start date: February 2015
• Est. completion date: February 2025

Study information

• Verified date: April 2018
• Source: U.S. Wound Registry
• Contact: Monica Weir, MBA, CCRP
• Phone: (800) 603-7896
• Email: monica.weir[@]uswoundregistry.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: February 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients with diabetic foot ulcers seen by the practitioner

Exclusion Criteria:

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer Outcome
• Foot Ulcer
• Quality of Patient Care
• Ulcer

Intervention

Biological:
• cellular and tissue based therapy

Device:
• negative pressure wound therapy

Procedure:
• debridement

• advanced wound therapy

Dietary Supplement:
• Nutritional screening

Device:
• off-loading

• Hyperbaric oxygen Therapy

Locations

Country	Name	City	State
United States	CHI St. Luke's The Woodlands	The Woodlands	Texas

Sponsors (2)

Lead Sponsor	Collaborator
U.S. Wound Registry	APMA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound healing	wound closure	6 months
Primary	major amputation	above the knee, below the knee	6 months
Primary	minor amputation with preservation of ambulation	toe amputation, transmetatarsal	6 months
Primary	Death	death without wound closure	6 months
Secondary	Patient Quality of life	W-QoL score	12 weeks
Secondary	Patient Reported Outcome	using patient reported outcome quality measure	12 months