An observational study in Venous Leg Ulcer, sponsored by Boston Scientific Corporation. Completed at 14 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-14.
Sponsored by Boston Scientific Corporation · Observational
Among 155 studies in Varicose Ulcer with a site in United States — 34 open to participants now, 43 under way, 4 of them phase 3. Varicose Ulcer · United States.
Among the 155 studies in Varicose Ulcer with a site in United States, this one is the 17th largest by enrollment of the 23 observational ones that give a count, is one of 6 that started in 2017, is one of 23 observational ones, and was the 81st registered.
369 studies on the registry are indexed under Varicose Ulcer; 77 are open to participants now.
Browse Varicose Ulcer studies →34 of the 155 studies in Varicose Ulcer with a site in United States are open now. Recruiting first, the newest first:
W.L.Gore & Associates · Sites in United States
Ages 18+
NuScience Medical Biologics, LLC · Sites in United States
Ages 18+
BioLab Holdings · Sites in United States
Ages 18+
Capsicure, LLC · Sites in United States
Ages 18+
BioLab Holdings · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 52 Varicose Ulcer studies recruiting now, 42 (81%) set no upper age limit and 5 (10%) stop at 75 or younger; 3 take children under 18; 4 take healthy volunteers.
This study: 18 Years and older · all sexes.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
155 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 11 · Phase 2 19 · Phase 3 10 · Phase 4 15
First in 2000; this study’s year is marked. 6 started in 2017.
This study's enrollment of 76 is below the median of 131 across 47 observational studies indexed under Varicose Ulcer.
Median enrollment 53 across the 132 interventional studies, 300 across the 23 observational. Of the 87 that completed or were terminated, 34 (39%) have results posted.
This tab as a report to print or save as PDF → With an account.
109 of 155 have an industry lead sponsor. The 10 most frequent:
Boston Scientific Corporation is the lead sponsor of 528 studies on the registry; 40 are open to participants now.
Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.
Boston Scientific Corporation has 1 study filed under Varicose Ulcer — fewer than ten, so there is no comparison to draw.
19 of the studies in Varicose Ulcer with a site in United States that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06568627Phase 3MediWound LtdA Double Blind Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement of VLU (VALUE) | 2026-12 |
| NCT06707103Phase 3TR TherapeuticsTissue Repair Gel in Venous Leg Ulcers in AU/US | 2026-12 |
| NCT06489028Phase 3RHEACELL GmbH & Co. KGAllogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Therapy-resistant CVU (Phase III) | 2027-04 |
| NCT06674980C5 BiomedicalClinical Trial Assessing Human Placental Membrane Products and Standard of Care Versus Standard of Care in Nonhealing DFUs and VLUs | 2026-11-22 |
| NCT06453187Integra LifeSciences CorporationA Modified Platform Trial of Multiple CAMPs for the Management of Diabetic Foot Ulcers and Venous Leg Ulcers | 2026-12-31 |
Among the 155 studies in Varicose Ulcer with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
A 12 month, multicenter, open-label registry to observe chronic venous insufficiency resulting in VLU treated with Varithena.
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.
Participants classified C6 on Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification with active VLU resulting from venous insufficiency of the GSV system and/or AASV
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Administration procedures and volume are per standard of care, full prescribing information, and instructions for use.
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to wound closure or to 12 months, whichever occurs first
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 12 months
Number of Ulcer Free Days
Mean number of ulcer free days defined as days from baseline to date of recurrence
Time frame: Baseline to 12 months
| Milestone | Prospective Registry Cohort |
|---|---|
| Started | 76 |
| Completed | 55 |
| Not completed | 21 |
| Withdrew: Withdrawal by subject | 7 |
| Withdrew: Lost to follow-up | 9 |
| Withdrew: Study discontinued by sponsor | 5 |
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.
| mm | Prospective Registry Cohort |
|---|---|
| at 12 weeks | 29.36 ± 146.13 |
| at 12 months | 43.64 ± 2.6 |
Total number of healed wounds at 12 weeks post treatment. Wound healing is measured measured by photograph inputted into wound measuring technology platform.
| wounds | Prospective Registry Cohort |
|---|---|
| Number of Wound Closure at 12 Weeks | 43 |
Median number of days to wound closure measured weekly. Wound closure as measured by photograph inputted into wound measuring technology platform.
| days | Prospective Registry Cohort |
|---|---|
| Time to Wound Closure | 89 (62 to 117) |
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.
| score on a scale | Prospective Registry Cohort |
|---|---|
| at 12 weeks | -1.4 ± 3.1 |
| at 12 months | -2.5 ± 3.1 |
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.
| score on a scale | Prospective Registry Cohort |
|---|---|
| at 12 weeks | 0.066 ± 0.233 |
| at 12 months | 0.072 ± 0.223 |
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.
| score on a scale | Prospective Registry Cohort |
|---|---|
| at 12 weeks | -5.8 ± 5.6 |
| at 12 months | -10.0 ± 7.1 |
Count of wounds remaining closed at 3 months post-wound closure determined via photograph and assessed by wound measurement technology platform.
| wounds | Prospective Registry Cohort |
|---|---|
| Number of Wounds Remaining Closed at 3 Months Post-wound Closure Date | 47 |
Count of wound recurrences of healed wounds. For healed wounds, VLU recurrence was collected via phone calls and subjects at follow up timelines.
| wounds | Prospective Registry Cohort |
|---|---|
| Number of Wound Recurrences | 7 (5.4 to 24.9) |
Mean number of ulcer free days defined as days from baseline to date of recurrence
| days | Prospective Registry Cohort |
|---|---|
| Number of Ulcer Free Days | 240.5 ± 118.9 |
Collected over Adverse events were collected during a 1 year period starting from the initiation of treatment until the subject completes the registry follow up period or withdraws.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Prospective Registry Cohort | 0/76 (0%) | 6/76 (7.9%) | 1/76 (1.3%) |
| Event | Prospective Registry Cohort |
|---|---|
| SepsisInfections and infestations | 2/76 |
| CellulitisInfections and infestations | 2/76 |
| Peripheral arterial occlusive diseaseVascular disorders | 1/76 |
| AstheniaGeneral disorders | 1/76 |
| Staphylococcal infectionInfections and infestations | 1/76 |
| Acute kidney injuryRenal and urinary disorders | 1/76 |
| Polyarteritis nodosaVascular disorders | 1/76 |
| GangreneVascular disorders | 1/76 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 1/76 |
| Toe amputationSurgical and medical procedures | 1/76 |
| Event | Prospective Registry Cohort |
|---|---|
| BlisterSkin and subcutaneous tissue disorders | 1/76 |
| Age, Categorical(Participants) | Prospective Registry Cohort |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 41 |
| >=65 years | 35 |
| Age, Continuous(years) | Prospective Registry Cohort |
|---|---|
| Mean | 63.6 ± 13.7 |
| Sex: Female, Male(Participants) | Prospective Registry Cohort |
|---|---|
| Female | 30 |
| Male | 46 |
| Race and Ethnicity Not Collected(Participants) | Prospective Registry Cohort |
|---|
| Region of Enrollment(participants) | Prospective Registry Cohort |
|---|---|
| Canada | 9 |
| United States | 67 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Sep 2017 to primary completion in May 2020, 31 months.
Results were first posted in Dec 2021, 1 year 6 months after primary completion.
Of 27 observational studies under Varicose Ulcer, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 141. This study's 31 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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