Varicose Veins LegDELICATVENCT03340246
Delayed or Immediate Local Treatment of Veins
A study testing Delayed sclerotherapy and Immediate phlebectomy in people with Varicose Veins Leg, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
Varicose veins affect a majority of adult patients and cause a decreased quality of life. In recent years, standard practice has been to perform thermoablation and local phlebectomies in the same procedure. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Varicose Veins Leg
- What is being tested?
- Delayed sclerotherapy and Immediate phlebectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteFinland
- Study dates
- 4 May 2016to 31 Dec 2022
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ultrasound verified insufficiency of great saphenous vein (GSV)
- GSV diameter 5-10 mm
- C2-C4 varicosities
- Most proximal insufficient branch in the distal thigh
- Written and signed informed consent
Who cannot join
- Peripheral arterial disease
- Body mass index >40
- Lymphoedema
- Known allergy to sclerosant
- Any known coagulopathy or history of deep vein thrombosis
- Severe illness
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Delayed or Immediate Local Treatment of Varicose Veins
Varicose veins affect a majority of adult patients and cause a decreased quality of life. In recent years, standard practice has been to perform thermoablation and local phlebectomies in the same procedure. There is conflicting data on the long-term outcome of the local varicose veins; there seems to be a need for more re-interventions if the local varicosities are not treated immediately. On the other hand, the prolonged combined procedure increases procedural pain and bleeding, as well as the risk for complications from deep vein thrombosis/pulmonary embolism.
This trial aims to evaluate the need for immediate treatment of local varicosities and the potential sufficiency of main trunk treatment.
- Conditions
- Varicose Veins Leg
- Being tested
- Delayed sclerotherapy, Immediate phlebectomy
- Keywords
- Varicose veins, phlebectomy
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delayed sclerotherapyProcedure or surgery
See arm descriptions
Immediate phlebectomyProcedure or surgery
See arm description
| Study group | Role | What they receive |
|---|---|---|
| Immediate phlebectomy | Active comparator | Mechanochemical ablation of main trunk and immediate phlebectomy of varicosities Receives: Procedure: Immediate phlebectomy |
| Delayed treatment | Experimental | Mechanochemical ablation of main trunk. Evaluation of varicosities at 3 months with sclerotherapy if required Receives: Procedure: Delayed sclerotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for sclerotherapy
Need for sclerotherapy of varicosities at three months after ablation of main trunk. Evaluated by the CEAP-classification of venous insufficiency. >C2 will be eligible for treatment.
Measured: 3 months
Secondary outcomes (2)
Patient satisfaction
Overall patient satisfaction and symptoms regarding varicosities and procedure at three months. Evaluated by the Aberdeen Varicose Veins Questionnaire (AVVQ). The AVVQ is a validated test, in which patients are asked to check boxes with regard to symptoms and quality of life (QoL). Scale 0-100, with 100 indicating worst possible QoL.
Measured: 3 months
Occlusion rate of great saphenous vein
Long-term occlusion rate of main trunk after mechanochemical ablation, evaluated by duplex ultrasound.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start4 May 2016
- Primary completion20 Dec 2020
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicose Veins LegStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe 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
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maarit Venermo, Helsinki University Central Hospital
- Investigators
- Karoliina Halmesmäki, M.D., Ph.D, Principal investigator, Helsinki University Central HospitalMaarit Venermo, M.D., Ph.D., Study director, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03340246
- Sponsor's protocol ID
- DELICATVE
- Acronym
- DELICATVE
- Status last verified
- Aug 2022
- First submitted
- 13 Oct 2017
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delayed or Immediate Local Treatment of Varicose Veins
- ClinicalTrials.gov ID
- NCT03340246
- Acronym / sponsor ID
- DELICATVE / DELICATVE
- Conditions
- Varicose Veins Leg
- Keywords
- Varicose veins, phlebectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 4 May 2016 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 13 Nov 2017 (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.
Varicose veins affect a majority of adult patients and cause a decreased quality of life. In recent years, standard practice has been to perform thermoablation and local phlebectomies in the same procedure. There is conflicting data on the long-term outcome of the local varicose veins; there seems to be a need for more re-interventions if the local varicosities are not treated immediately. On the other hand, the prolonged combined procedure increases procedural pain and bleeding, as well as the risk for complications from deep vein thrombosis/pulmonary embolism.
This trial aims to evaluate the need for immediate treatment of local varicosities and the potential sufficiency of main trunk treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate phlebectomy | Active comparator | Procedure: Immediate phlebectomyMechanochemical ablation of main trunk and immediate phlebectomy of varicosities |
| Delayed treatment | Experimental | Procedure: Delayed sclerotherapyMechanochemical ablation of main trunk. Evaluation of varicosities at 3 months with sclerotherapy if required |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ultrasound verified insufficiency of great saphenous vein (GSV)
- GSV diameter 5-10 mm
- C2-C4 varicosities
- Most proximal insufficient branch in the distal thigh
- Written and signed informed consent
Key exclusion criteria (7 listed)
- Peripheral arterial disease
- Body mass index >40
- Lymphoedema
- Known allergy to sclerosant
- Any known coagulopathy or history of deep vein thrombosis
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 |
|---|---|---|
| Delayed sclerotherapySee arm descriptions | Procedure or surgery | Delayed treatment |
| Immediate phlebectomySee arm description | Procedure or surgery | Immediate phlebectomy |
Primary outcome
Need for sclerotherapy
Time frame: 3 months
Need for sclerotherapy of varicosities at three months after ablation of main trunk. Evaluated by the CEAP-classification of venous insufficiency. >C2 will be eligible for treatment.
2 secondary outcomes
Patient satisfaction
Time frame: 3 months
Occlusion rate of great saphenous vein
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Individual participant dataSharing planned: Undecided
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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.
Karoliina Halmesmäki, M.D., Ph.D principal investigator
Helsinki University Central Hospital
Maarit Venermo, M.D., Ph.D. study director
Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delayed sclerotherapy and Immediate phlebectomy in people with Varicose Veins Leg, run by Helsinki University Central Hospital at 1 site in Finland.
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 5 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: status not confirmed, as of the sponsor's last update on 9 Aug 2022. 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 Finland. 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?
Results are not available in the source record.
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?
Need for sclerotherapy (time frame: 3 months). 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 9 Aug 2022.