Diabetic Foot UlcersNPWTRNCT02467998
Negative Pressure Wound 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 Negative Pressure Wound Therapy Registry (NPWTR) 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 effectiveness and safety of various NPWT devices and methods among patients with chronic wounds and… 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?
- NPWT
- Type of treatment
- Medical device
- How many people
- 50,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Jan 2020
- How long will I take part?
- 3 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 undergoing treatment with NPWT
Who may be able to join
- Provision of NPWT
Who cannot join
- patients not undergoing NPWT
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
Sherrill White Wolfe, 936-266-2150, swhitewolfe@stlukeshealth.org
About this study
Official title: The Registry of Negative Pressure Wound Therapy for Chronic Wounds and Ulcers
The goal of the Negative Pressure Wound Therapy Registry (NPWTR) 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 effectiveness and safety of various NPWT devices and methods 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 Randomized Controlled Trials (RCTs) tend to be non-generalizable. Little is known about the effectiveness of NPWT among typical patients. Patient registries are also ideal for assessing long term safety issues in these devices.
Read the detailed description
The purpose of the Negative Pressure Wound Therapy Registry (NPWTR)) for Wounds and Ulcers is to provide comparative effectiveness data on NPWT including different NPWT devices, and safety data on NPWT (e.g. the frequency of adverse events experienced by typical NPWT patients).
NPWT promotes wound healing by applying a vacuum through a special sealed dressing. The mechanical micro-deformation of the wound bed in response to suction has been shown to stimulate and accelerate the formation of new blood vessels (angiogenesis). The continuous vacuum removes fluid and reduces edema, thereby increasing tissue oxygen levels. The vacuum may be applied continuously or intermittently, depending on the type of wound being treated and the clinical objectives. Depending on the NPWT device, a variety of dressings are placed into the wound bed in conjunction with NPWT, and a variety of suction pressures may be applied.
The diversity of NPWT devices 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 NPWT in wound healing.
Hospital based outpatient wound centers participating in the US Wound Registry agree to provide data as part of quality initiatives including participation in PQRS, and to meet their Stage 2 Meaningful use criteria. The NPWTR is a subset of the USWR (Chronic Disease Registry) data. All patient data from all participating outpatient clinics are transmitted to the USWR where data are available for benchmarking, PQRS and other initiatives. Data used for comparative effectiveness research is HIPAA de-identified.
- Conditions
- Diabetic Foot Ulcers, Venous Stasis Ulcer, Pressure Ulcer, Surgical Wound Dehiscence, Burns, Other Types of Chronic Non Healing Wounds
- Being tested
- NPWT
- Keywords
- meaningful use, electronic health records, structured language, NPWT, PQRS
- Medical subject headings
- Diabetic Foot, Varicose Ulcer, Pressure Ulcer, Surgical Wound Dehiscence, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPWTDevice
Also called the VAC, Renasys, Pico, Engenix
SVAP polyurethane foam, RENASYS foam, RENASYS gauze, AMD gauze, VAC white sponge, VAC black sponge, applied with various NPWT devices, in addition to various dressings to protect wound edges
| Study group | Role | What they receive |
|---|---|---|
| NPWT treated wounds | NPWT from any FDA cleared NPWT device including Receives: Device: NPWT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing
Time-to-event for wound closure
Measured: In days from the start of NPWT until the date healing or closure by other means, or of death from any cause, whichever came first, assessed up to 12 months
Secondary outcomes (2)
Duration of NPWT
Counting total amount of therapy delivered
Measured: In days from date of NPWT initiation until the date of last NPWT treatment regardless of patient outcome, assessed up to 12 months
Side effects and adverse Events During Therapy
Overall catalog of event types and occurrences. Score in % for: bleeding, retention of foam or other interface in wound bed, periwound breakdown, worsening of wound such as exposure of deep structure, and wound infection
Measured: Events occurring between initial treatment and cessation of NPWT treatment. Event outcome information will be as recorded or status at 30 days following onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (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.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50,000 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- U.S. Wound Registry
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline Fife, MD, Principal investigator, US Wound Registry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02467998
- Sponsor's protocol ID
- CDR003
- Acronym
- NPWTR
- Status last verified
- Apr 2018
- First submitted
- 24 Nov 2014
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fife CE, Walker D, Thomson B, Otto G. The safety of negative pressure wound therapy using vacuum-assisted closure in diabetic foot ulcers treated in the outpatient setting. Int Wound J. 2008 Jun;5 Suppl 2(Suppl 2):17-22. doi: 10.1111/j.1742-481X.2008.00467.x.
PubMed 18577134Fife CE, Carter MJ. Wound Care Outcomes and Associated Cost Among Patients Treated in US Outpatient Wound Centers: Data From the US Wound Registry. Wounds. 2012 Jan;24(1):10-7.
PubMed 25875947Fife CE, Otto G, Walker D, Turner T, Smith L. Healing dehisced surgical wounds with negative pressure wound therapy. Ostomy Wound Manage. 2004 Apr;50(4A Suppl):28-31. No abstract available.
PubMed 15317243
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 Negative Pressure Wound Therapy for Chronic Wounds and Ulcers
- ClinicalTrials.gov ID
- NCT02467998
- Acronym / sponsor ID
- NPWTR / CDR003
- Conditions
- Diabetic Foot Ulcers, Venous Stasis Ulcer, Pressure Ulcer, Surgical Wound Dehiscence, Burns, Other Types of Chronic Non Healing Wounds
- Keywords
- meaningful use, electronic health records, structured language, NPWT, PQRS
- 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
- 10 Jun 2015 (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 Negative Pressure Wound Therapy Registry (NPWTR) 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 effectiveness and safety of various NPWT devices and methods 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 Randomized Controlled Trials (RCTs) tend to be non-generalizable. Little is known about the effectiveness of NPWT among typical patients. Patient registries are also ideal for assessing long term safety issues in these devices.
Detailed description
The purpose of the Negative Pressure Wound Therapy Registry (NPWTR)) for Wounds and Ulcers is to provide comparative effectiveness data on NPWT including different NPWT devices, and safety data on NPWT (e.g. the frequency of adverse events experienced by typical NPWT patients).
NPWT promotes wound healing by applying a vacuum through a special sealed dressing. The mechanical micro-deformation of the wound bed in response to suction has been shown to stimulate and accelerate the formation of new blood vessels (angiogenesis). The continuous vacuum removes fluid and reduces edema, thereby increasing tissue oxygen levels. The vacuum may be applied continuously or intermittently, depending on the type of wound being treated and the clinical objectives. Depending on the NPWT device, a variety of dressings are placed into the wound bed in conjunction with NPWT, and a variety of suction pressures may be applied.
The diversity of NPWT devices 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 NPWT in wound healing.
Hospital based outpatient wound centers participating in the US Wound Registry agree to provide data as part of quality initiatives including participation in PQRS, and to meet their Stage 2 Meaningful use criteria. The NPWTR is a subset of the USWR (Chronic Disease Registry) data. All patient data from all participating outpatient clinics are transmitted to the USWR where data are available for benchmarking, PQRS and other initiatives. Data used for comparative effectiveness research is HIPAA de-identified.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NPWT treated wounds | – | Device: NPWTNPWT from any FDA cleared NPWT device including |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients undergoing treatment with NPWT
Key inclusion criteria (1 listed)
- Provision of NPWT
Key exclusion criteria (1 listed)
- patients not undergoing NPWT
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 |
|---|---|---|
| NPWTAlso: the VAC, Renasys, Pico, EngenixSVAP polyurethane foam, RENASYS foam, RENASYS gauze, AMD gauze, VAC white sponge, VAC black sponge, applied with various NPWT devices, in addition to various dressings to protect wound edges | Device | NPWT treated wounds |
Primary outcome
Healing
Time frame: In days from the start of NPWT until the date healing or closure by other means, or of death from any cause, whichever came first, assessed up to 12 months
Time-to-event for wound closure
2 secondary outcomes
Duration of NPWT
Time frame: In days from date of NPWT initiation until the date of last NPWT treatment regardless of patient outcome, assessed up to 12 months
Side effects and adverse Events During Therapy
Time frame: Events occurring between initial treatment and cessation of NPWT treatment. Event outcome information will be as recorded or status at 30 days following onset
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.
- Background: PubMed 18577134Fife CE, Walker D, Thomson B, Otto G. The safety of negative pressure wound therapy using vacuum-assisted closure in diabetic foot ulcers treated in the outpatient setting. Int Wound J. 2008 Jun;5 Suppl 2(Suppl 2):17-22. doi: 10.1111/j.1742-481X.2008.00467.x.
- Background: PubMed 25875947Fife CE, Carter MJ. Wound Care Outcomes and Associated Cost Among Patients Treated in US Outpatient Wound Centers: Data From the US Wound Registry. Wounds. 2012 Jan;24(1):10-7.
- Background: PubMed 15317243Fife CE, Otto G, Walker D, Turner T, Smith L. Healing dehisced surgical wounds with negative pressure wound therapy. Ostomy Wound Manage. 2004 Apr;50(4A Suppl):28-31. No abstract available.
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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.
Caroline Fife, MD principal investigator
US Wound Registry
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: In days from the start of NPWT until the date healing or closure by other means, or of death from any cause, whichever came first, assessed up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02467998, which also lists 3 linked publications.
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.