Venous Leg UlcerVIEW-VLUNCT03257254
Effect of VarIthena on Wound Healing in Venous Leg Ulcers (VLU)
An observational study of Venous Leg Ulcer, run by Boston Scientific Corporation at 14 sites in 2 countries.
Trial summary
A 12 month, multicenter, open-label registry to observe chronic venous insufficiency resulting in VLU treated with Varithena. 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?
- Varithena
- How many people
- 76 participants
- Where
- 14 sitesin 2 countries
- Study dates
- 29 Sep 2017to 28 Sep 2020
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Participants classified C6 on Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification with active VLU resulting from venous insufficiency of the GSV system and/or AASV
Who may be able to join
- Men and women; age ≥18
- Investigator has selected Varithena® to treat participants classified C6 with chronic (≥3 months) VLU resulting from GSV and/or AASV incompetence
- Wound can be visualized in one plane to allow for image collection of the entire wound in one photograph, or if wound is circumferential, participant must be able to capture the entire wound using multiple photographs taken from directly above the wound (straight on)
- Reflux >500 milliseconds (ms) on duplex ultrasound
- Willing and able to collect wound photographs and data using an application installed on a tablet
- Willing and able to return for scheduled follow-up and wound care visits
- Ability to comprehend and sign informed consent form (ICF) and complete questionnaires
Who cannot join
- Contraindications to Varithena® 1% in accordance with the FPI
- Any serious concomitant disease, per physician's discretion, that confounds wound healing, including malignant changes of wound
- Concomitant heat ablation, or heat ablation of index leg within 6 weeks prior to treatment with Varithena®
- Significant arterial disease or ankle-brachial pressure index (ABPI) ≤0.8
- In the opinion of Investigator, wound would close within 12 weeks without additional treatment
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United States13 sites
Emory University Hospital
Atlanta, Georgia, 30306
Pines Clinical Research
Aventura, Florida, 33180
Lake Washington Vascular, PLLC
Bellevue, Washington, 98004
Mass General, Boston
Boston, Massachusetts, 02114
The Venous Institute of Buffalo
Buffalo, New York, 14226
Swedish Covenant Hospital
Chicago, Illinois, 60625
Mercy Health Cincinnati -West Hospital
Cincinnati, Ohio, 45211
OhioHealth Research
Columbus, Ohio, 43214
The Vascular Experts
Darien, Connecticut, 06820
University of Texas Health Sciences Center at Houston
Houston, Texas, 77030
Totality
Oklahoma City, Oklahoma, 73118
Stanford University
Palo Alto, California, 94304
University of California Davis Health
Sacramento, California, 95817
About this study
Official title: Observational Study of the Effect of VarIthena® on Wound Healing in the Treatment of Venous Leg Ulcers Resulting From Chronic Venous Insufficiency
A 12 month, multicenter, open-label registry to observe chronic venous insufficiency resulting in VLU treated with Varithena.
Read the detailed description
This 12 month, multicenter, open-label registry is designed to collect treatment and outcome data related to participants treated with Varithena for great saphenous vein (GSV) system and/or anterior accessory saphenous vein (AASV) incompetence resulting in VLU. Participant are treated per Investigator's Standard of Care (SoC) and in accordance with the Full Prescribing Information (FPI) and Instructions for Use (IFU). For participants with healed ulcers during the 12 month follow-up period, VLU recurrence information is collected.
- Conditions
- Venous Leg Ulcer
- Being tested
- Varithena
- Keywords
- GSV, AASV, Vein, Venous, Ulcer, Varicose Vein, VLU, venous insufficiency, venous disease, chronic VLU
- Medical subject headings
- Varicose Ulcer, Ulcer, Varicose Veins, Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VarithenaDrug
Administration procedures and volume are per standard of care, full prescribing information, and instructions for use.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Wound Perimeter
Mean change in wound perimeter as measured by photograph inputted into wound measuring technology platform. Larger number indicates a lower wound perimeter compared to baseline. Epithelial migration measured by change in perimeter of wound.
Measured: Baseline to 12 weeks and to 12 months
Number of Wound Closure at 12 Weeks
Total number of healed wounds at 12 weeks post treatment. Wound healing is measured measured by photograph inputted into wound measuring technology platform.
Measured: Baseline to 12 weeks
Time to Wound Closure
Median number of days to wound closure measured weekly. Wound closure as measured by photograph inputted into wound measuring technology platform.
Measured: Baseline to wound closure or to 12 months, whichever occurs first
Secondary outcomes (6)
Change in Pain
Mean change in pain on numeric pain rating scale (NPRS) compared to baseline at 12 months post-treatment. Minimum value is "0" and maximum value is "10". Higher scores mean a worse outcome.
Measured: Baseline to 12 weeks and to 12 months
Change on EQ-5D-5L Quality of Life Assessment
Mean change on 5-level EQ-5D (EQ-5D-5L) quality of life assessment compared to baseline at 12 months post-treatment. Minimum value is "0" and maximum value is "1". Higher score mean better outcome.
Measured: Baseline to 12 weeks and to 12 months
Change in VCSS
Mean change in Venous Clinical Severity Score (VCSS) from baseline to 12 month follow up. VCSS assesses nine common signs/symptoms of venous disease and each item is scored individually with a minimum score of "0" and maximum score of "3". The individual items are added together to assess change from baseline. Higher scores mean worst outcome.
Measured: Baseline to 12 weeks and to 12 months
Number of Wounds Remaining Closed at 3 Months Post-wound Closure Date
Count of wounds remaining closed at 3 months post-wound closure determined via photograph and assessed by wound measurement technology platform.
Measured: Baseline to 12 months
Number of Wound Recurrences
Count of wound recurrences of healed wounds. For healed wounds, VLU recurrence was collected via phone calls and subjects at follow up timelines.
Measured: Baseline to 12 months
Number of Ulcer Free Days
Mean number of ulcer free days defined as days from baseline to date of recurrence
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start29 Sep 2017
- Primary completion18 May 2020
- Study completion28 Sep 2020
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 Leg UlcerStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Shao, MD, Principal investigator, Swedish Covenant Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03257254
- Sponsor's protocol ID
- BTG-001652-01
- Acronym
- VIEW-VLU
- Status last verified
- Nov 2021
- First submitted
- 16 Aug 2017
- Last updated
- 14 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of the Effect of VarIthena® on Wound Healing in the Treatment of Venous Leg Ulcers Resulting From Chronic Venous Insufficiency
- ClinicalTrials.gov ID
- NCT03257254
- Acronym / sponsor ID
- VIEW-VLU / BTG-001652-01
- Conditions
- Venous Leg Ulcer
- Keywords
- GSV, AASV, Vein, Venous, Ulcer, Varicose Vein, VLU, venous insufficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 29 Sep 2017 (actual)
- Primary completion
- 18 May 2020 (actual)
- Study completion
- 28 Sep 2020 (actual)
- First posted
- 22 Aug 2017 (actual)
- Results
- Posted 14 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A 12 month, multicenter, open-label registry to observe chronic venous insufficiency resulting in VLU treated with Varithena.
Detailed description
This 12 month, multicenter, open-label registry is designed to collect treatment and outcome data related to participants treated with Varithena for great saphenous vein (GSV) system and/or anterior accessory saphenous vein (AASV) incompetence resulting in VLU. Participant are treated per Investigator's Standard of Care (SoC) and in accordance with the Full Prescribing Information (FPI) and Instructions for Use (IFU). For participants with healed ulcers during the 12 month follow-up period, VLU recurrence information is collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participants classified C6 on Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification with active VLU resulting from venous insufficiency of the GSV system and/or AASV
Key inclusion criteria (7 listed)
- Men and women; age ≥18
- Investigator has selected Varithena® to treat participants classified C6 with chronic (≥3 months) VLU resulting from GSV and/or AASV incompetence
- Wound can be visualized in one plane to allow for image collection of the entire wound in one photograph, or if wound is circumferential, participant must be able to capture the entire wound using multiple photographs taken from directly above the wound (straight on)
- Reflux >500 milliseconds (ms) on duplex ultrasound
- Willing and able to collect wound photographs and data using an application installed on a tablet
Key exclusion criteria (5 listed)
- Contraindications to Varithena® 1% in accordance with the FPI
- Any serious concomitant disease, per physician's discretion, that confounds wound healing, including malignant changes of wound
- Concomitant heat ablation, or heat ablation of index leg within 6 weeks prior to treatment with Varithena®
- Significant arterial disease or ankle-brachial pressure index (ABPI) ≤0.8
- In the opinion of Investigator, wound would close within 12 weeks without additional treatment
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 |
|---|---|---|
| VarithenaAdministration procedures and volume are per standard of care, full prescribing information, and instructions for use. | Drug | – |
Primary outcome
Change From Baseline in Wound Perimeter
Time frame: Baseline to 12 weeks and to 12 months
Mean change in wound perimeter as measured by photograph inputted into wound measuring technology platform. Larger number indicates a lower wound perimeter compared to baseline. Epithelial migration measured by change in perimeter of wound.
Number of Wound Closure at 12 Weeks
Time frame: Baseline to 12 weeks
Total number of healed wounds at 12 weeks post treatment. Wound healing is measured measured by photograph inputted into wound measuring technology platform.
Time to Wound Closure
Time frame: Baseline to wound closure or to 12 months, whichever occurs first
Median number of days to wound closure measured weekly. Wound closure as measured by photograph inputted into wound measuring technology platform.
6 secondary outcomes
Change in Pain
Time frame: Baseline to 12 weeks and to 12 months
Change on EQ-5D-5L Quality of Life Assessment
Time frame: Baseline to 12 weeks and to 12 months
Change in VCSS
Time frame: Baseline to 12 weeks and to 12 months
Number of Wounds Remaining Closed at 3 Months Post-wound Closure Date
Time frame: Baseline to 12 months
Number of Wound Recurrences
Time frame: Baseline to 12 months
Number of Ulcer Free Days
Time frame: Baseline to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Michael Shao, MD principal investigator
Swedish Covenant Hospital
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Leg Ulcer, run by Boston Scientific Corporation at 14 sites in 2 countries.
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 7 inclusion and 5 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 14 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Canada. 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?
Yes. Results are posted in the registry (first posted 14 Dec 2021). 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?
Change From Baseline in Wound Perimeter (time frame: Baseline to 12 weeks and to 12 months). The study lists 3 primary outcomes in all. 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 14 Dec 2021.