AzTrials
AzTrials

Venous MalformationNCT07066527

Efficacy and Safety Analysis of Polylauric Alcohol More Stable Foam Versus Ordinary Foam in the Treatment of Head and Neck Venous Malformations

A study testing The addition of sodium hyaluronate to poly (cinnamyl alcohol-RRB- produces a more stable foam in people with Venous Malformation, run by Qilu Hospital of Shandong University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The aim of this study is to explore the efficacy and safety of poly -LRB-cinnamyl alcohol) foam in the treatment of venous malformations of head and neck through a prospective randomized clinical trial, this trial may provide better treatment options and evidence for head and neck VMs. Read more about this study

Who is it for?
Ages 14 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Venous Malformation
What is being tested?
The addition of sodium hyaluronate to poly (cinnamyl alcohol-RRB- produces a more stable foam
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteChina
Study dates
1 Jun 2022to 30 Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 14 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Age 14-60 years of age, sex unlimited (except pregnant women or those preparing for pregnancy)
  • Clinical diagnosis and imaging () were consistent with head and neck venous malformations
  • Participants volunteered to participate in the trial and signed an informed consent form.

Who cannot join

  • People with serious systemic diseases, including heart disease, high blood pressure, diabetes, etc. , that are not under control. Heart Attack: 1. Recent frequent attacks of angina. 2. Recent history of myocardial infarction 3. Cardiac function grade iii-iv or with symptoms of sitting breathing, cyanosis, jugular venous distension, lower limb edema, etc. . 4. Heart disease complicated with hypertension 5. Type II or III Type II atrioventricular block, double bundle branch block, as syndrome, diabetes: blood sugar control in 8.88 mmol/L above, hypertension: after taking medicine blood pressure can not be controlled in the normal range namely systolic pressure below 140 mmhg, diastolic pressure below 90 mmhg)
  • Patients who are unable to follow up on time;
  • Persons who are mentally ill or have mental disorders;
  • The patient or his/her authorized person is unwilling to sign a written informed consent or comply with the protocol

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

shaohua liu, Doctoral contact

+8618560083730

lshabccba@126.com

weiliang zhang, Bachelor contact

+8613678613566

814831990@qq.com

China1 site, 1 recruiting
  • Shandong University Qilu Hospital

    Jinan, Shandong, 250000

    shaohua liu, PhD, +86 185 6008 3730, lshabccba@126.com

    Recruiting

Other trials in China

About this study

Official title: Efficacy and Safety Analysis of More Stable Foam and Ordinary Foam Based on Polylauricol in the Treatment of Head and Neck Venous Malformations: a Prospective, Randomized and Controlled Study

The aim of this study is to explore the efficacy and safety of poly -LRB-cinnamyl alcohol) foam in the treatment of venous malformations of head and neck through a prospective randomized clinical trial, this trial may provide better treatment options and evidence for head and neck VMs.

Read the detailed description

Foam sclerotherapy is an effective method for the treatment of venous malformations in head and neck, which has been widely used in the world in recent years. The foam hardener is a kind of uniform microfoam formed by the mixture of surfactant liquid hardener and a certain proportion of gas. The microfoam has fluidity and can be injected into the cavity of venous malformation, the foam can replace the blood in the Lacuna, and can expel the blood, the foam occupies the lesion lacuna, makes the hardener be diluted by the blood to the minimum degree, so that the function concentration of the hardener can be guaranteed, the foam can contact the endothelial cells of venous malformations, acting as the contact betthe investigatorsen the liquid hardener and the endothelial cells, and the foam is less mobile than the liquid hardener, so the foam can be replaced by the blood for a longer time than the liquid hardener, sclerosants can affect endothelial cells for a long time. The disadvantage of liquid hardeners is that they are diluted by blood, leading to an insufficient level of desired effect at the injection site and into the normal venous system. In contrast, foam hardeners replace blood rather than mix with it and occupy the interior of blood vessels. The foam blocks blood flow, increasing the time of contact betthe investigatorsen the Hardener and the vessel wall. Foam hardeners are more effective than liquid hardeners in treating VMS. There are many factors that affect the therapeutic effect of foam hardening, such as the types of hardeners and the stability of foam, among which the stability of foam is one of the key factors that affect the therapeutic effect of foam hardening, the stability of the foam is affected by many factors, such as the type, concentration, liquid-gas ratio, gas type and temperature of the Hardener. The half-life, the time it takes for a foam to reduce its volume to half its original volume (half-volume) , is widely used to assess foam stability. According to the study, the half-life of 1% poly (cinnamyl alcohol-RPol(POL) foam with a liquid-to-gas ratio of 1:4 was 142.8(64.32) seconds, in this study, the half-life of the foam made from 1% POL containing 0.05% hyaluronic acid (HA) was 390.4(613.06) seconds, human blood contains a certain amount of HA, according to the literature reported that 0.05% concentration of HA injected into human blood is safe, so this more stable foam preparation method was patented, and published in international journals. Our team used more stable POL foam to treat head and neck VMs, which was found to be safe and effective by retrospective study. The results of this study have been published in international journal. It has also been reported that glycerol added to the sclerosing agent polydocanol or sodium tetradecyl sulfate can enhance the stability of the foam. The foam produced by glycerol has been used in the treatment of VMS of the head and neck for more than 2 years, and that a more stable bubble might work better. Therefore, whether the more stable hardening agent foam will have better therapeutic effect and whether its safety is different from that of ordinary foam, there is only conjecture and no clear evidence to ansthe investigatorsr this question. Therefore, on the basis of the previous research, a prospective randomized clinical trial was conducted to evaluate the efficacy and safety of polycinol foam in the treatment of venous malformations in the head and neck region, this trial may provide better treatment options and evidence for head and neck VMs.

Being tested
The addition of sodium hyaluronate to poly (cinnamyl alcohol-RRB- produces a more stable foam

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The addition of sodium hyaluronate to poly (cinnamyl alcohol-RRB- produces a more stable foamCombination product

    According to the study, the half-life of 1% poly (cinnamyl alcohol-RPol(POL) foam with a liquid-to-gas ratio of 1:4 was 142.8(64.32) seconds, in this study, the half-life of the foam made from 1% POL containing 0.05% hyaluronic acid (HA) was 390.4(613.06) seconds, human blood contains a certain amount of HA, according to the literature reported that 0.05% concentration of HA injected into human blood is safe, so this more stable foam preparation method was patented, and published in international journals.

Study groups in NCT07066527
Study groupRoleWhat they receive
A common foam prepared from poly (cinnamyl alcohol)No intervention1% POL solution 2ml + 8ml air was used to produce foam by Tessari's method for head and neck VMs
More stable foams made from poly -LRB-cinnamyl alcohol)Active comparator0.05% 0.1 ml hyaluronic acid+1% POL solution 2ml + 8ml air was used to produce foam by Tessari's method for head and neck VMs
Receives: Combination Product: The addition of sodium hyaluronate to poly (cinnamyl alcohol-RRB- produces a more stable foam

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Remission rate of venous malformations in head and neck

    Patients were satisfied and no further treatment was needed after clinical evaluation. This was the last treatment. The proportion of patients who responded to treatment was counted and compared between the two groups.

    Measured: 3-4 weeks after treatment

Secondary outcomes (3)
  1. Volume of venous malformation

    The volume changes of venous malformations were compared before and after treatment. The patients were examined by MRI before operation and after the last treatment

    Measured: 3-4 weeks after treatment

  2. Foam injection

    The total foam volume from the first treatment to the end of treatment was recorded.

    Measured: 3-4 weeks after treatment

  3. Number of treatment

    Statistics of patients with the first treatment to the last treatment of the total number of treatments.

    Measured: According to the condition whether need to be treated again, is generally 3-4 weeks for a treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2025
  2. Study start1 Jun 2022
  3. Primary completion30 Dec 2025 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

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
Single blind
Who is masked
Participant
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07066527
Sponsor's protocol ID
KYLL-202207-006-2
Status last verified
May 2025
First submitted
20 Mar 2025
Last updated
15 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing The addition of sodium hyaluronate to poly (cinnamyl alcohol-RRB- produces a more stable foam in people with Venous Malformation, run by Qilu Hospital of Shandong University at 1 site in China.

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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 15 Jul 2025. 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 China. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact shaohua liu, Doctoral (+8618560083730, lshabccba@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Remission rate of venous malformations in head and neck (time frame: 3-4 weeks after treatment). 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 15 Jul 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in