Pressure UlcersPhase 4NCT01734109
Efficacy of Quantum NPWT With Simultaneous Irrigation on Reduction of Wound Volume in Stage III/IV Pressure Ulcers.
A Phase 4 study testing Quantum Negative Pressure Wound Therapy Device in people with Pressure Ulcers, run by Innovative Therapies, Inc. at 1 site in United States.
Trial summary
Negative-pressure wound therapy (NPWT) is an important adjunct for management of wounds, and promotes granulation tissue and angiogenesis. Despite these known means for facilitation of wound management, further research is needed to examine whether this modality is superior to other currently used options, thus… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pressure Ulcers
- What is being tested?
- Quantum Negative Pressure Wound Therapy Device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Mar 2014
- Phase
- Phase 4
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female between the ages of 18 and 70
- Any patient with a stage III/IV pressure ulcer of the size large enough to indicate use of Negative Pressure Treatment.
Who cannot join
- Clinical evidence of active, gross infection.
- Patient or patient's guardian refuses consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Henry Ford Hospital System
Detroit, Michigan, 48202
Kenneth Moquin, MD
About this study
Official title: A 12-week, Single Site, Randomized Controlled Trial to Compare the Efficacy of Quantum NPWT With and Without Simultaneous Irrigation Versus Standard of Care on Reduction of the Volume of Stage III/IV Pressure Ulcers.
Negative-pressure wound therapy (NPWT) is an important adjunct for management of wounds, and promotes granulation tissue and angiogenesis. Despite these known means for facilitation of wound management, further research is needed to examine whether this modality is superior to other currently used options, thus defining clear indications for and benefits of NPWT. This would also help establish the role of combination therapy, using NPWT with simultaneous irrigation or other forms of dressings. This study aims to compare treatment efficacy of NPWT, NPWT plus proprietary simultaneous irrigation, and traditional hospital standard of care for treatment of grade III \& IV pressure ulcers. Primary endpoint of this study is comparison of reduction of wound volume between the three treatment arms; and secondary endpoints include bacterial load, rate of wound healing, preparation for grafting, and pain.
- Conditions
- Pressure Ulcers
- Being tested
- Quantum Negative Pressure Wound Therapy Device
- Keywords
- Negative Pressure Wound Therapy, Irrigation Therapy, Pressure Ulcers, Sacral Ulcers
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantum Negative Pressure Wound Therapy DeviceDevice
Also called Quantum NPWT
To compare the additional benefit of Quantum Negative pressure wound therapy device with and without simultaneous irrigation.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care - Wound Care | Placebo comparator | Standard, acceptable local wound care management, consisting of topical treatments, chemical debriders, or light bedside debridement. |
| Quantum NPWT | Active comparator | Intervention with Quantum NPWT to Standard III/IV pressure ulcers for 12 weeks. Receives: Device: Quantum Negative Pressure Wound Therapy Device |
| Quantum NPWT with Irrigation | Active comparator | NPWT with the Quantum device, with the addition of simultaneous irrigation using 0.25% acetic acid. Receives: Device: Quantum Negative Pressure Wound Therapy Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of reduction in wound volume between Quantum with Irrigation v Standard of Care
Comparison of reduction in wound volume between Quantum with Irrigation versus standard of care over 12 weeks treatment period.
Measured: 12-weeks
Secondary outcomes (1)
Comparison of reduction in wound volume between Quantum with Irrigation v Quantum without irrigation
Comparison of reduction in wound volume between Quantum with Irrigation versus Quantum without irrigation over 12 weeks measurement period.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study startDec 2012
- Primary completionSep 2013 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovative Therapies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sandra J Berriman, Ph.D., Study director, Innovative Therapies, Inc.Kenneth Moquin, MD, Principal investigator, Henry Ford Hospital System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01734109
- Sponsor's protocol ID
- ITIQ002A
- Status last verified
- Nov 2012
- First submitted
- 21 Nov 2012
- Last updated
- 28 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-week, Single Site, Randomized Controlled Trial to Compare the Efficacy of Quantum NPWT With and Without Simultaneous Irrigation Versus Standard of Care on Reduction of the Volume of Stage III/IV Pressure Ulcers.
- ClinicalTrials.gov ID
- NCT01734109
- Acronym / sponsor ID
- ITIQ002A
- Conditions
- Pressure Ulcers
- Keywords
- Negative Pressure Wound Therapy, Irrigation Therapy, Pressure Ulcers, Sacral Ulcers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Innovative Therapies, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 27 Nov 2012 (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.
Negative-pressure wound therapy (NPWT) is an important adjunct for management of wounds, and promotes granulation tissue and angiogenesis. Despite these known means for facilitation of wound management, further research is needed to examine whether this modality is superior to other currently used options, thus defining clear indications for and benefits of NPWT. This would also help establish the role of combination therapy, using NPWT with simultaneous irrigation or other forms of dressings. This study aims to compare treatment efficacy of NPWT, NPWT plus proprietary simultaneous irrigation, and traditional hospital standard of care for treatment of grade III \& IV pressure ulcers. Primary endpoint of this study is comparison of reduction of wound volume between the three treatment arms; and secondary endpoints include bacterial load, rate of wound healing, preparation for grafting, and pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard of Care - Wound Care | Placebo comparator | –Standard, acceptable local wound care management, consisting of topical treatments, chemical debriders, or light bedside debridement. |
| Quantum NPWT | Active comparator | Device: Quantum Negative Pressure Wound Therapy DeviceIntervention with Quantum NPWT to Standard III/IV pressure ulcers for 12 weeks. |
| Quantum NPWT with Irrigation | Active comparator | Device: Quantum Negative Pressure Wound Therapy DeviceNPWT with the Quantum device, with the addition of simultaneous irrigation using 0.25% acetic acid. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or Female between the ages of 18 and 70
- Any patient with a stage III/IV pressure ulcer of the size large enough to indicate use of Negative Pressure Treatment.
Key exclusion criteria (2 listed)
- Clinical evidence of active, gross infection.
- Patient or patient's guardian refuses consent.
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 |
|---|---|---|
| Quantum Negative Pressure Wound Therapy DeviceAlso: Quantum NPWTTo compare the additional benefit of Quantum Negative pressure wound therapy device with and without simultaneous irrigation. | Device | Quantum NPWT, Quantum NPWT with Irrigation |
Primary outcome
Comparison of reduction in wound volume between Quantum with Irrigation v Standard of Care
Time frame: 12-weeks
Comparison of reduction in wound volume between Quantum with Irrigation versus standard of care over 12 weeks treatment period.
1 secondary outcome
Comparison of reduction in wound volume between Quantum with Irrigation v Quantum without irrigation
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2012.
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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.
Sandra J Berriman, Ph.D. study director
Innovative Therapies, Inc.
Kenneth Moquin, MD principal investigator
Henry Ford Hospital System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Quantum Negative Pressure Wound Therapy Device in people with Pressure Ulcers, run by Innovative Therapies, Inc. 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 2 inclusion and 2 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 28 Nov 2012. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Kenneth Moquin, MD (734-301-1083, kmoquin1@hfhs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of reduction in wound volume between Quantum with Irrigation v Standard of Care (time frame: 12-weeks). 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 28 Nov 2012.