Diabetic Foot Ulcer OutcomeDFURNCT02813161
The Diabetic Foot Ulcer Registry
An observational study of Diabetic Foot Ulcer Outcome and Quality of Patient Care, run by U.S. Wound Registry at 1 site in United States.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetic Foot Ulcer Outcome, Quality of Patient Care
- What is being tested?
- cellular and tissue based therapy, negative pressure wound therapy and debridement
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Feb 2025
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Prospectively followed diabetic foot ulcers in the practice of clinicians submitting data to the registry
Who may be able to join
- All patients with diabetic foot ulcers seen by the practitioner
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
CHI St. Luke's The Woodlands
The Woodlands, Texas, 77384
Sherrill White Wolfe, 936-266-2150, swhitewolfe@StLukesHealth.org
About this study
Official title: A Real World, Observational Registry of Diabetic Foot Ulcers and Quality of Care in Clinical Practice
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.
Read the detailed 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.
- Being tested
- cellular and tissue based therapy, negative pressure wound therapy, debridement, advanced wound therapy, Nutritional screening
- Keywords
- diabetic foot ulcer, diabetes, arterial disease, neuropathy, amputation, QCDR, quality measure, wound
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cellular and tissue based therapyBiological
Also called Apligraf, Dermagraft, Theraskin, Epifix
negative pressure wound therapyDevice
Also called The VAC, Pico, SnAP
debridementProcedure or surgery
advanced wound therapyProcedure or surgery
Nutritional screeningDietary supplement
off-loadingDevice
Also called TCC EZ-Cast, Total Contact Casting, CROW walker, shoe modification
Hyperbaric oxygen TherapyDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing
wound closure
Measured: 6 months
major amputation
above the knee, below the knee
Measured: 6 months
minor amputation with preservation of ambulation
toe amputation, transmetatarsal
Measured: 6 months
Death
death without wound closure
Measured: 6 months
Secondary outcomes (2)
Patient Quality of life
W-QoL score
Measured: 12 weeks
Patient Reported Outcome
using patient reported outcome quality measure
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study startFeb 2015
- Primary completionJan 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot Ulcer OutcomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- U.S. Wound Registry
- Sponsor type
- University, hospital or other
- Collaborators
- APMA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02813161
- Sponsor's protocol ID
- CDR005
- Acronym
- DFUR
- Status last verified
- Apr 2018
- First submitted
- 10 Jun 2016
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real World, Observational Registry of Diabetic Foot Ulcers and Quality of Care in Clinical Practice
- ClinicalTrials.gov ID
- NCT02813161
- Acronym / sponsor ID
- DFUR / CDR005
- Keywords
- diabetic foot ulcer, diabetes, arterial disease, neuropathy, amputation, QCDR, quality measure, wound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- U.S. Wound RegistryUniversity, hospital or other
- Collaborators
- APMA
- Study start
- Feb 2015 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 24 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Prospectively followed diabetic foot ulcers in the practice of clinicians submitting data to the registry
Key inclusion criteria (1 listed)
- All patients with diabetic foot ulcers seen by the practitioner
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cellular and tissue based therapyAlso: Apligraf, Dermagraft, Theraskin, Epifix | Biological | – |
| negative pressure wound therapyAlso: The VAC, Pico, SnAP | Device | – |
| debridement | Procedure or surgery | – |
| advanced wound therapy | Procedure or surgery | – |
| Nutritional screening | Dietary supplement | – |
| off-loadingAlso: TCC EZ-Cast, Total Contact Casting, CROW walker, shoe modification | Device | – |
| Hyperbaric oxygen Therapy | Device | – |
Primary outcome
Wound healing
Time frame: 6 months
wound closure
major amputation
Time frame: 6 months
above the knee, below the knee
minor amputation with preservation of ambulation
Time frame: 6 months
toe amputation, transmetatarsal
Death
Time frame: 6 months
death without wound closure
2 secondary outcomes
Patient Quality of life
Time frame: 12 weeks
Patient Reported Outcome
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot Ulcer Outcome and Quality of Patient Care, run by U.S. Wound Registry at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Monica Weir, MBA, CCRP ((800) 603-7896, monica.weir@uswoundregistry.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2018.