Wound HealingPhase 2NCT01022216
Efficacy Study of a Bioelectric Dressing Used With Negative Pressure Wound Therapy to Treat Diabetic and Pressure Ulcers
A Phase 2 study testing Procellera™ Wound Dressing with V.A.C.® Therapy and V.A.C.® Therapy in people with Wound Healing, run by Vomaris Innovations at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a bioelectric wound dressing, used in conjunction with Negative Pressure Wound Therapy (NPWT), is effective in the treatment of diabetic and pressure ulcers of the foot. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Wound Healing
- What is being tested?
- Procellera™ Wound Dressing with V.A.C.® Therapy and V.A.C.® Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Nov 2011
- Phase
- Phase 2
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Wound size greater than 1x1 cm
- Wounds must be ≥5 cm away from all other wounds
- Wound size must not be diminished in size greater than 10% between enrollment in study and the prescreening
- Participant must be candidate for negative pressure wound therapy
- Participant agrees to participate in follow-up evaluations
- Participant must be able to read and understand informed consent, and sign the informed consent
Who cannot join
- Concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study
- Participant is to receive another topical agent (antimicrobials, enzymes, etc.) other than the study dressing (granufoam)
- Participant is to receive Silver granufoam for their wound
- Participant with sensitivity or adverse reactions to silver or zinc
- Pregnancy or nursing an infant or child
- Immunosuppression
Show all 9Show fewer
- Active or systemic infection
- Participant undergoing active cancer chemotherapy
- Chronic steroid use
Trial locations and contacts
1 site in 1 country.
United States1 site
Wyckoff Heights Medical Center
Brooklyn, New York, 11237
About this study
Official title: A Randomized, Controlled Trial of the Procellera™ Wound Dressing Used With Negative Pressure Wound Therapy (NPWT) in the Healing of Diabetic and Pressure Ulcers of the Foot
The purpose of this study is to determine whether a bioelectric wound dressing, used in conjunction with Negative Pressure Wound Therapy (NPWT), is effective in the treatment of diabetic and pressure ulcers of the foot.
- Conditions
- Wound Healing
- Being tested
- Procellera™ Wound Dressing with V.A.C.® Therapy, V.A.C.® Therapy
- Keywords
- Wound, Skin lesion, Antimicrobial, Bioelectric, Diabetic foot, Pressure Ulcer
- Medical subject headings
- Wounds and Injuries, Diabetic Foot, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procellera™ Wound Dressing with V.A.C.® TherapyDevice
Also called PROCELLERA™, PROSIT™, Bioelectric
Dressing indicated for partial and full-thickness wounds. Weekly dressing changes, more frequently if needed. Used as a primary contact layer in conjunction with NPWT.
V.A.C.® TherapyDevice
Also called Negative Pressure Wound Therapy, Vacuum Assisted Closure, V.A.C.® Therapy,
Vacuum Assisted Closure device that uses controlled negative pressure, with dressing changes 1x/week.
| Study group | Role | What they receive |
|---|---|---|
| V.A.C.® Therapy | Active comparator | Vacuum Assisted Closure device that utilizes controlled negative pressure Receives: Device: V.A.C.® Therapy |
| Procellera™ Wound Dressing with V.A.C.® Therapy | Experimental | Procellera wound dressing used as a primary contact layer on the wound bed, used in conjunction with NPWT Receives: Device: Procellera™ Wound Dressing with V.A.C.® Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing over time
Measured: 3 months after enrollment
Secondary outcomes (1)
Pain reduction
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2009 (estimated)
- Study startAug 2009
- Primary completionAug 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealingStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vomaris Innovations
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ronald M Guberman, DPM, Principal investigator, Wyckoff Heights Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01022216
- Sponsor's protocol ID
- XSMP-013
- Status last verified
- Feb 2012
- First submitted
- 24 Nov 2009
- Last updated
- 22 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial of the Procellera™ Wound Dressing Used With Negative Pressure Wound Therapy (NPWT) in the Healing of Diabetic and Pressure Ulcers of the Foot
- ClinicalTrials.gov ID
- NCT01022216
- Acronym / sponsor ID
- XSMP-013
- Conditions
- Wound Healing
- Keywords
- Wound, Skin lesion, Antimicrobial, Bioelectric, Diabetic foot, Pressure Ulcer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Vomaris InnovationsIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 1 Dec 2009 (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 purpose of this study is to determine whether a bioelectric wound dressing, used in conjunction with Negative Pressure Wound Therapy (NPWT), is effective in the treatment of diabetic and pressure ulcers of the foot.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| V.A.C.® Therapy | Active comparator | Device: V.A.C.® TherapyVacuum Assisted Closure device that utilizes controlled negative pressure |
| Procellera™ Wound Dressing with V.A.C.® Therapy | Experimental | Device: Procellera™ Wound Dressing with V.A.C.® TherapyProcellera wound dressing used as a primary contact layer on the wound bed, used in conjunction with NPWT |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Wound size greater than 1x1 cm
- Wounds must be ≥5 cm away from all other wounds
- Wound size must not be diminished in size greater than 10% between enrollment in study and the prescreening
- Participant must be candidate for negative pressure wound therapy
- Participant agrees to participate in follow-up evaluations
Key exclusion criteria (9 listed)
- Concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study
- Participant is to receive another topical agent (antimicrobials, enzymes, etc.) other than the study dressing (granufoam)
- Participant is to receive Silver granufoam for their wound
- Participant with sensitivity or adverse reactions to silver or zinc
- Pregnancy or nursing an infant or child
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 |
|---|---|---|
| Procellera™ Wound Dressing with V.A.C.® TherapyAlso: PROCELLERA™, PROSIT™, BioelectricDressing indicated for partial and full-thickness wounds. Weekly dressing changes, more frequently if needed. Used as a primary contact layer in conjunction with NPWT. | Device | Procellera™ Wound Dressing with V.A.C.® Therapy |
| V.A.C.® TherapyAlso: Negative Pressure Wound Therapy, Vacuum Assisted Closure, V.A.C.® Therapy,Vacuum Assisted Closure device that uses controlled negative pressure, with dressing changes 1x/week. | Device | V.A.C.® Therapy |
Primary outcome
Wound healing over time
Time frame: 3 months after enrollment
1 secondary outcome
Pain reduction
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 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.
Ronald M Guberman, DPM principal investigator
Wyckoff Heights Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Procellera™ Wound Dressing with V.A.C.® Therapy and V.A.C.® Therapy in people with Wound Healing, run by Vomaris Innovations 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 6 inclusion and 9 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: finished, as of the sponsor's last update on 22 Feb 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing over time (time frame: 3 months after enrollment). 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 22 Feb 2012.