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Clinical Trials in China / NCT07066527
Recruiting Not applicable

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

NCT07066527 · tracked via the Priya Life Science China tracker
Sponsor
Qilu Hospital of Shandong University
Phase
Not applicable
Started
2022-06-01
Last updated
2025-07-15

Condition(s) studied

Venous Malformation

Investigational drug(s) / intervention(s)

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

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

Eligibility

Sex
ALL
Min age
14 Years
Max age
60 Years
Healthy volunteers
Accepted
Inclusion Criteria: 1. Age 14-60 years of age, sex unlimited (except pregnant women or those preparing for pregnancy) 2. Clinical diagnosis and imaging () were consistent with head and neck venous malformations 3. Participants volunteered to participate in the trial and signed an informed consent form. Exclusion Criteria: 1. 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) 2. Patients who are unable to follow up on time; 3. Persons who are mentally ill or have mental disorders; 4. The patient or his/her authorized person is unwilling to sign a written informed consent or comply with the protocol

Primary outcome measure(s)

  • Remission rate of venous malformations in head and neck — 3-4 weeks after treatment
    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.

Trial sites (1)

FacilityCityRegionStatus
Shandong University Qilu Hospital Jinan Shandong Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07066527 on ClinicalTrials.gov ↗ ← All trials in China