Venous Stasis UlcersPhase 4NCT01567150
Wound Fluid Protease Levels During Use of Novel Wound Dressing
A Phase 4 study testing Novel Dressing in people with Venous Stasis Ulcers, run by Hollister Incorporated at 8 sites in United States.
Trial summary
This study is being conducted to characterize the way leg wounds respond to a new type of wound dressing, compared to wounds in patients who are not using the new dressing. The investigators will collect wound fluid for biochemical analysis, and they will measure the wound healing that occurs with and without the new… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Stasis Ulcers
- What is being tested?
- Novel Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 8 sitesUnited States
- Study dates
- Feb 2012to Jan 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of venous insufficiency
- One or more partial or full-thickness venous leg ulcers 5-24 sq. cm in size without evidence of clinical infection
- Ankle/brachial index 0.8 and above
- Duration of wound up to one year
- Able to return to wound clinic for weekly evaluations
- Has signed Institutional Review Board approved informed consent
Who cannot join
- Exposed bone or tendon or necrotic wound base
- Signs or symptoms of cellulitis or osteomyelitis at the target ulcer
- Allergy to a component of the novel dressing or compression wrap
- Third degree burn
- Vasculitis, severe rheumatoid arthritis or other collagen vascular disease
- Receiving antibiotics
- Pregnant or lactating
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Circleville Foot & Ankle
Circleville, Ohio, 43113
Baylor University Medical Center
Dallas, Texas, 75246
Alexian Brothers Medical Center Wound Healing Center
Elk Grove Village, Illinois, 60007
Genesys Regional Medical Center
Grand Blanc, Michigan, 48439
University of Miami, Department of Surgery, Div. of Vascular Surgery
Miami, Florida, 33136
NYU Langone Medical Center
New York, New York, 10010
Arizona Heart Hospital
Phoenix, Arizona, 85006
Phoenix Baptist Hospital
Phoenix, Arizona, 85015
About this study
This study is being conducted to characterize the way leg wounds respond to a new type of wound dressing, compared to wounds in patients who are not using the new dressing. The investigators will collect wound fluid for biochemical analysis, and they will measure the wound healing that occurs with and without the new dressing.
Read the detailed description
Abnormal wound healing is characterized by prolonged inflammation and excess degradation of the extracellular matrix through the activity of proteinases and other enzymes. Wound fluids can provide biochemical information about the healing status of chronic wounds and the effects of wound treatments. In this study the investigators will obtain samples of wound fluid and measure healing in wounds randomized to receive the novel dressing or a control. The findings will be compared between the two groups.
- Conditions
- Venous Stasis Ulcers
- Being tested
- Novel Dressing
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel DressingDevice
Topical wound dressing
| Study group | Role | What they receive |
|---|---|---|
| novel dressing | Active comparator | Treatment with novel dressing Receives: Device: Novel Dressing |
| Control | No intervention | Control is treatment without novel dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Matrix Metalloproteinase Level in Wound Fluid
Wound fluid will be collected and analyzed at baseline and approximately every 7 days.
Mean was calculated for each subject. Means and standard deviation were calculated for the treatment and control groups.
Measured: 8 weeks
Secondary outcomes (1)
Wound Healing
change in wound area mean was calculated for each subject Mean and sd were calculated for each group
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 posted30 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Venous Stasis 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hollister Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ginger Salvadalena, PhD, RN, Study director, Hollister Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01567150
- Sponsor's protocol ID
- 5064-W
- Status last verified
- Oct 2016
- First submitted
- 23 Mar 2012
- Last updated
- 25 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wound Fluid Protease Levels During Use of Novel Wound Dressing
- ClinicalTrials.gov ID
- NCT01567150
- Acronym / sponsor ID
- 5064-W
- Conditions
- Venous Stasis Ulcers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Hollister IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 30 Mar 2012 (estimated)
- Results
- Posted 25 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to characterize the way leg wounds respond to a new type of wound dressing, compared to wounds in patients who are not using the new dressing. The investigators will collect wound fluid for biochemical analysis, and they will measure the wound healing that occurs with and without the new dressing.
Detailed description
Abnormal wound healing is characterized by prolonged inflammation and excess degradation of the extracellular matrix through the activity of proteinases and other enzymes. Wound fluids can provide biochemical information about the healing status of chronic wounds and the effects of wound treatments. In this study the investigators will obtain samples of wound fluid and measure healing in wounds randomized to receive the novel dressing or a control. The findings will be compared between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| novel dressing | Active comparator | Device: Novel DressingTreatment with novel dressing |
| Control | No intervention | –Control is treatment without novel dressing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of venous insufficiency
- One or more partial or full-thickness venous leg ulcers 5-24 sq. cm in size without evidence of clinical infection
- Ankle/brachial index 0.8 and above
- Duration of wound up to one year
- Able to return to wound clinic for weekly evaluations
Key exclusion criteria (7 listed)
- Exposed bone or tendon or necrotic wound base
- Signs or symptoms of cellulitis or osteomyelitis at the target ulcer
- Allergy to a component of the novel dressing or compression wrap
- Third degree burn
- Vasculitis, severe rheumatoid arthritis or other collagen vascular disease
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 |
|---|---|---|
| Novel DressingTopical wound dressing | Device | novel dressing |
Primary outcome
Matrix Metalloproteinase Level in Wound Fluid
Time frame: 8 weeks
Wound fluid will be collected and analyzed at baseline and approximately every 7 days. Mean was calculated for each subject. Means and standard deviation were calculated for the treatment and control groups.
1 secondary outcome
Wound Healing
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Venous Stasis Ulcers
Recruiting
The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study
Venous Thromboses, Venous Disease
Active, not recruiting
The GORE® VIABAHN® FORTEGRA Venous Stent IVC Study
Venous Thromboses, Venous Disease
RecruitingPhase 2
MTX-001 for the Treatment of Non-Healing Venous Stasis Ulcers
Venous Stasis Ulcer, Venous Leg Ulcer
Active, not recruiting
The GORE® VIABAHN® FORTEGRA Venous Stent Iliofemoral Study
Venous Thromboses, Venous Disease
RecruitingPhase 3
Tissue Repair Gel in Venous Leg Ulcers (US)
Venous Leg Ulcer, Venous Ulcer
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.
Ginger Salvadalena, PhD, RN study director
Hollister Incorporated
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Novel Dressing in people with Venous Stasis Ulcers, run by Hollister Incorporated at 8 sites 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 7 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 25 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 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?
Yes. Results are posted in the registry (first posted 25 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Matrix Metalloproteinase Level in Wound Fluid (time frame: 8 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 25 Nov 2016; AzTrials last refreshed its copy on 7 Nov 2026.