Diabetic Foot UlcersCTPRNCT02322554
Cellular and Tissue Based Therapy Registry
An observational study of Diabetic Foot Ulcers and Venous Stasis Ulcer, run by U.S. Wound Registry at 1 site in United States.
Trial summary
The goal of the Cellular and Tissue Based Therapy Registry (CTPR) for Wounds is to provide real world patient data from electronic health records submitted to meet Stage 2 Meaningful Use in order to understand the value of these products among patients with chronic wounds and ulcers. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetic Foot Ulcers, Venous Stasis Ulcer, Pressure Ulcer
- What is being tested?
- Cellular and tissue based products
- How many people
- 50,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Jan 2020
- How long will I take part?
- 2 Months
- 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: All patients seen at participating hospital based outpatient wound centers to whom CTPs are applied
Who may be able to join
- patients receiving cellular and tissue based products
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
St. Luke's Wound Care Clinic
The Woodlands, Texas, 77384
Caroline Fife, MD, 936-266-2150, Cfife@intellicure.com
Sherrill White Wolfe, (936) 266-2150, swhitewolfe@stlukeshealth.org
About this study
Official title: The Registry of Cellular and Tissue Based Therapies for Chronic Wounds and Ulcers
The goal of the Cellular and Tissue Based Therapy Registry (CTPR) for Wounds is to provide real world patient data from electronic health records submitted to meet Stage 2 Meaningful Use in order to understand the value of these products among patients with chronic wounds and ulcers. Randomized, controlled trials to establish product efficacy routinely exclude patients with the co-morbid conditions common to patients seen in usual clinical practice and thus the results of these RCTs tend to be non-generalizable. Little is known about the effectiveness of CTPs among typical patients.
Read the detailed description
The goal of the Cellular and Tissue Based Therapy Registry (CTPR) for Wounds is to provide comparative effectiveness data for patients with chronic wounds and ulcers and to understand whether clinical practice guidelines are followed in the use of these products. These products are referred to by a variety of names of which are inaccurate reflections of their structure or purpose (e.g. Cellular and Engineered Tissue Alternatives, "bioengineered tissues," "biological dressings"). The preferred term is cellular and/or tissue based products (CTPs). CTPs are utilized for their biological influence on the healing process by stimulating or supporting healing. They may or may not be incorporated into regenerating tissue. Both tissue derived and biosynthetic products may be made with or without dead cells and biomaterials made of living cells may be comprised of autologous cells (cultured and not cultured), xenogenic, or allogenic cells (minimally manipulated, cultured, immortal).The diversity of products and the rate at which they are becoming available for clinical use make it impossible to perform randomized controlled trials to compare their effectiveness against one another. Effectiveness in real world patients is the best current option to understand the role of CTPs in wound healing.
Hospital based outpatient wound centers participating in the US Wound Registry agree to provide data as part of quality initiatives and to meet their Stage 2 Meaningful use criteria. The CTPR is a subset of the USWR data. All patient data from all participating outpatient clinics are transmitted to the USWR where it is available for benchmarking, PQRS and other initiatives. Data used for effectiveness research is HIPAA de-identified. These data are derived from structured language entries directly transmitted from electronic health records which also link to billing and charge documents once practitioners sign and lock charts, confirming the veracity of data entries.
- Conditions
- Diabetic Foot Ulcers, Venous Stasis Ulcer, Pressure Ulcer, Chronic Non Healing Wound, Surgical Wound Dehiscence
- Being tested
- Cellular and tissue based products
- Keywords
- electronic health records, Qualified Clinical Data Registry, PQRS, quality reporting, cellular based products, bioengieered skin, USWR
- Medical subject headings
- Diabetic Foot, Varicose Ulcer, Pressure Ulcer, Surgical Wound Dehiscence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cellular and tissue based productsBiological
Also called Apligraf, Dermagraft, Epifix, Oasis
Procedure: Application of device or biological to wounds
| Study group | Role | What they receive |
|---|---|---|
| wounds treated with CTPs | All cellular and tissue based products currently reimbursed in the hospital based outpatient department, administered at intervals as determined in the course of clinical practice Receives: Biological: Cellular and tissue based products |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing
Healing or wound closure by wound type and stratified by Wound Healing Index
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 posted23 Dec 2014 (estimated)
- Study startJan 2005
- Primary completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcersStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 50,000 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- U.S. Wound Registry
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02322554
- Sponsor's protocol ID
- CDR002
- Acronym
- CTPR
- Status last verified
- Apr 2018
- First submitted
- 23 Nov 2014
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Registry of Cellular and Tissue Based Therapies for Chronic Wounds and Ulcers
- ClinicalTrials.gov ID
- NCT02322554
- Acronym / sponsor ID
- CTPR / CDR002
- Conditions
- Diabetic Foot Ulcers, Venous Stasis Ulcer, Pressure Ulcer, Chronic Non Healing Wound, Surgical Wound Dehiscence
- Keywords
- electronic health records, Qualified Clinical Data Registry, PQRS, quality reporting, cellular based products, bioengieered skin, USWR
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- U.S. Wound RegistryUniversity, hospital or other
- Study start
- Jan 2005 (actual)
- Primary completion
- Jan 2020 (estimated)
- First posted
- 23 Dec 2014 (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.
The goal of the Cellular and Tissue Based Therapy Registry (CTPR) for Wounds is to provide real world patient data from electronic health records submitted to meet Stage 2 Meaningful Use in order to understand the value of these products among patients with chronic wounds and ulcers. Randomized, controlled trials to establish product efficacy routinely exclude patients with the co-morbid conditions common to patients seen in usual clinical practice and thus the results of these RCTs tend to be non-generalizable. Little is known about the effectiveness of CTPs among typical patients.
Detailed description
The goal of the Cellular and Tissue Based Therapy Registry (CTPR) for Wounds is to provide comparative effectiveness data for patients with chronic wounds and ulcers and to understand whether clinical practice guidelines are followed in the use of these products. These products are referred to by a variety of names of which are inaccurate reflections of their structure or purpose (e.g. Cellular and Engineered Tissue Alternatives, "bioengineered tissues," "biological dressings"). The preferred term is cellular and/or tissue based products (CTPs). CTPs are utilized for their biological influence on the healing process by stimulating or supporting healing. They may or may not be incorporated into regenerating tissue. Both tissue derived and biosynthetic products may be made with or without dead cells and biomaterials made of living cells may be comprised of autologous cells (cultured and not cultured), xenogenic, or allogenic cells (minimally manipulated, cultured, immortal).The diversity of products and the rate at which they are becoming available for clinical use make it impossible to perform randomized controlled trials to compare their effectiveness against one another. Effectiveness in real world patients is the best current option to understand the role of CTPs in wound healing.
Hospital based outpatient wound centers participating in the US Wound Registry agree to provide data as part of quality initiatives and to meet their Stage 2 Meaningful use criteria. The CTPR is a subset of the USWR data. All patient data from all participating outpatient clinics are transmitted to the USWR where it is available for benchmarking, PQRS and other initiatives. Data used for effectiveness research is HIPAA de-identified. These data are derived from structured language entries directly transmitted from electronic health records which also link to billing and charge documents once practitioners sign and lock charts, confirming the veracity of data entries.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| wounds treated with CTPs | – | Biological: Cellular and tissue based productsAll cellular and tissue based products currently reimbursed in the hospital based outpatient department, administered at intervals as determined in the course of clinical practice |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients seen at participating hospital based outpatient wound centers to whom CTPs are applied
Key inclusion criteria (1 listed)
- patients receiving cellular and tissue based products
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 productsAlso: Apligraf, Dermagraft, Epifix, OasisProcedure: Application of device or biological to wounds | Biological | wounds treated with CTPs |
Primary outcome
Healing
Time frame: 12 months
Healing or wound closure by wound type and stratified by Wound Healing Index
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2018.
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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 Ulcers and Venous Stasis Ulcer, 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 1 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 Caroline E Fife, MD (800-603-7896, cfife@uswoundregistry.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing (time frame: 12 months). 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 1 May 2018.