Venous Leg UlcerNCT03450616
Pilot Study Comparing Negative Pressure Dressings to Conventional Dressings
A study testing PICO Negative Pressure Wound Therapy and Compression Dressing in people with Venous Leg Ulcer, run by Northwell Health at 1 site in United States.
Trial summary
This study is being conducted to determine how the PICO™ Negative Pressure Wound Therapy compares to standard care treatment for venous stasis ulcers, as there is no evidence to date. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcer
- What is being tested?
- PICO Negative Pressure Wound Therapy and Compression Dressing
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2019to Dec 2019
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with bilateral venous leg ulcers (one on each lower extremity) (defined as any break in the skin that has either been present for longer than 6 wks or occurred in a person with a history of venous leg ulceration).
- The ulcer is required to be venous in appearance (ie: moist, shallow, and of an irregular shape), and judged unlikely to heal within 21 days.
- 18 years old or older
- Have an ankle brachial pressure index of at least 0.8 that was measured within the previous 3 months.
Who cannot join
- • Patients on anticoagulants- (ie: warfarin, direct thrombin inhibitors).
- Patients who have a pressure index measured within the previous 3 months to be greater than 1.20
- Patients with venous stasis ulcers greater than 17cm by 17cm.
- Gross leg edema
- Severe wound exudate
- Patients with malignancy in the wound bed or margins of the wound
Show all 10Show fewer
- Previously confirmed and untreated osteomyelitis.
- Patients with necrotic tissue with eschar present.
- Patients with wounds that involve exposed arteries, veins, nerves, bone fragments or sharp edges.
- Patients with wounds that requires surgical suction.
Trial locations and contacts
1 site in 1 country.
United States1 site
Staten Island University Hospital
Staten Island, New York, 10305
About this study
Official title: Pilot Study Comparing Negative Pressure Dressings to Conventional Dressings for the Management of Patients With Venous Stasis Ulcers.
This study is being conducted to determine how the PICO™ Negative Pressure Wound Therapy compares to standard care treatment for venous stasis ulcers, as there is no evidence to date.
Read the detailed description
This is a single-blind, randomized pilot study conducted in patients with bilateral venous stasis leg ulcers.
The aim of the study is to compare the rate of healing for venous stasis ulcers when using the PICO™ single use Negative pressure wound therapy (NPWT) system versus standard care.
The primary objective is to determine if the PICO™ NPWT system results in an increased rate of healing when compared to standard of care for the treatment of venous stasis ulcers.
- Conditions
- Venous Leg Ulcer
- Being tested
- PICO Negative Pressure Wound Therapy, Compression 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.
PICO Negative Pressure Wound TherapyDevice
Negative Pressure Wound Therapy Device
Compression DressingProcedure or surgery
Standard of Care Compression Dressing
| Study group | Role | What they receive |
|---|---|---|
| Negative Pressure Wound Therapy | Experimental | Subjects will have one venous stasis ulcer treated with the PICO Negative Pressure Wound Therapy Device Receives: Device: PICO Negative Pressure Wound Therapy |
| Compression Dressing- Standard of Care | Active comparator | Subjects will have one venous stasis ulcer treated with the standard of care compression dressing. Receives: Procedure: Compression Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of healing
Surface area and depth of wound measurements will be collected to determine rate of healing
Measured: Weekly for three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study startJun 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Why it stopped: Unable to begin study due to funding. PI has left organization
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg UlcerStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All subjects will receive both treatment arms at the same time.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03450616
- Sponsor's protocol ID
- 17-0951
- Status last verified
- May 2019
- First submitted
- 23 Feb 2018
- Last updated
- 29 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data will not be made available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Comparing Negative Pressure Dressings to Conventional Dressings for the Management of Patients With Venous Stasis Ulcers.
- ClinicalTrials.gov ID
- NCT03450616
- Acronym / sponsor ID
- 17-0951
- Conditions
- Venous Leg Ulcer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to begin study due to funding. PI has left organization
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Jun 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 1 Mar 2018 (actual)
- 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.
This study is being conducted to determine how the PICO™ Negative Pressure Wound Therapy compares to standard care treatment for venous stasis ulcers, as there is no evidence to date.
Detailed description
This is a single-blind, randomized pilot study conducted in patients with bilateral venous stasis leg ulcers.
The aim of the study is to compare the rate of healing for venous stasis ulcers when using the PICO™ single use Negative pressure wound therapy (NPWT) system versus standard care.
The primary objective is to determine if the PICO™ NPWT system results in an increased rate of healing when compared to standard of care for the treatment of venous stasis ulcers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- All subjects will receive both treatment arms at the same time.
| Arm | Type | Receives |
|---|---|---|
| Negative Pressure Wound Therapy | Experimental | Device: PICO Negative Pressure Wound TherapySubjects will have one venous stasis ulcer treated with the PICO Negative Pressure Wound Therapy Device |
| Compression Dressing- Standard of Care | Active comparator | Procedure: Compression DressingSubjects will have one venous stasis ulcer treated with the standard of care compression dressing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient with bilateral venous leg ulcers (one on each lower extremity) (defined as any break in the skin that has either been present for longer than 6 wks or occurred in a person with a history of venous leg ulceration).
- The ulcer is required to be venous in appearance (ie: moist, shallow, and of an irregular shape), and judged unlikely to heal within 21 days.
- 18 years old or older
- Have an ankle brachial pressure index of at least 0.8 that was measured within the previous 3 months.
Key exclusion criteria (10 listed)
- • Patients on anticoagulants- (ie: warfarin, direct thrombin inhibitors).
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 |
|---|---|---|
| PICO Negative Pressure Wound TherapyNegative Pressure Wound Therapy Device | Device | Negative Pressure Wound Therapy |
| Compression DressingStandard of Care Compression Dressing | Procedure or surgery | Compression Dressing- Standard of Care |
Primary outcome
Rate of healing
Time frame: Weekly for three weeks
Surface area and depth of wound measurements will be collected to determine rate of healing
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2019.
- Individual participant dataSharing planned: No. Data will not be made available to other researchers.
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The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PICO Negative Pressure Wound Therapy and Compression Dressing in people with Venous Leg Ulcer, run by Northwell Health 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 4 inclusion and 10 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: withdrawn, as of the sponsor's last update on 29 May 2019. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Rate of healing (time frame: Weekly for three 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 29 May 2019; AzTrials last refreshed its copy on 7 Nov 2026.