An observational study in Probable Capillary Malformation-Arteriovenous Malformation Syndrome, sponsored by Second Affiliated Hospital of Xi'an Jiaotong University. Completed at 1 site in China. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2025-05-22.
Sponsored by Second Affiliated Hospital of Xi'an Jiaotong University · Observational
This study aims to reduce the misdiagnosis rate of PWSs and improve the diagnosis of CM-AVM using ultrasound. Furthermore, we seek to provide more evidence-based recommendations for the treatment of patients with probable CM-AVM syndrome, particularly those presenting with erythema.
Background: Exacerbation of erythema following photodynamic therapy (PDT) in patients with probable capillary malformation-arteriovenous malformation (CM-AVM) syndrome, may be attributed to misdiagnosis as port-wine stains (PWSs).
Objective: To identify the ultrasound features of patients with exacerbation of erythema following PDT for a definite diagnosis.
Methods: A retrospective single-center study was conducted on PWS patients with exacerbation of erythema following PDT. The clinical and ultrasonic features were reviewed and analysed. One low-frequency and two high-frequency ultrasound (HFUS) devices were used to examine the lesions and the contralateral normal skin.
Results: The clinical characteristics of 16 patients were consistent with those of high-flow vascular stains (HFVS). Ultrasound findings revealed skin and hypodermis thickening, increased blood flow signals with an arteriovenous malformation (AVM) waveform and deeper, larger blood vessels in the dermis and hypodermis of pink macules (PMs) compared to normal skin. In the absence of genetic diagnosis, PWS patients with exacerbation of erythema following PDT were diagnosed as having probable CM-AVM syndrome.
Limitations: Retrospective single-center design and small sample size. Conclusion: Patients with PWSs are advised to undergo low-frequency ultrasound examinations to avoid misdiagnosis. HFUS can serve as a complementary method to promptly identify underlying AVMs beneath the PMs. We do not recommend PDT treatment for patients with probable CM-AVM syndrome.
92 studies on the registry are indexed under Arteriovenous Malformations; 29 are open to participants now.
This study's enrollment of 16 is below the median of 100 across 41 observational studies indexed under Arteriovenous Malformations.
Browse Arteriovenous Malformations studies →Second Affiliated Hospital of Xi'an Jiaotong University is the lead sponsor of 70 studies on the registry; 16 are open to participants now.
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Patients experiencing exacerbation of clinical symptoms, such as darker coloration than before treatment, following at least one Hemoporfin-PDT session were recruited between 2017 and 2023 at the Department of Dermatology, Second Affiliated Hospital of Xi'an Jiaotong University.
Inclusion Criteria:
Patients who were greater than or equal to 1 year old at the time of their first HMME-PDT treatment.
Patients who experiencing exacerbation of clinical symptoms, such as darker coloration than before treatment.
Patients experiencing exacerbation of clinical symptoms, such as darker coloration than before treatment, following at least one Hemoporfin-PDT session were recruited.
Combination Product: HMME-PDT · Device: Ultrasound examinations
Prior to treatment, patients or their guardians provided written informed consent. Then patients were then prepared for the procedure by fully exposing the treatment area and shielding the surrounding normal skin with a black cloth. Hemoporfin (Shanghai Fudan-Zhangjiang Bio-Pharmaceutical) was administrated intravenously at a dosage of 5.0 mg/kg. Subsequently, patients underwent light radiation at 532 nm (Wuhan Yage Optic and Electronic Technique, Wuhan, China) for 18 to 25 minutes, with a power density randing form 75 to 110 mW/cm2.
Ultrasound examinations were performed using three types of devices: a Paragon XHD equipped with a L38-22 probe operating at a frequency of 20-30 MHz (Kolo Medical Co., Ltd, Suzhou, China), a DUB Skin Scanner with a 22 MHz probe (Taberna Pro Medicum, German), or a Mindray Resona 7 featuring an L14-5WU linear probe set to a frequency range of 11-12 MHz frequency (Mindray Bio-Medical Electronics Co., Ltd, Shenzhen, China).
ultrasound characteristics
After cleaning and disinfecting the mesured area, the probe, coated with 1-2 millimeters of coupling agent, was positioned vertically on the skin surface. Measurements of skin thickness, density, vessel diameter, and depth were obtained for both the lesions and the contralateral normal skin. The color Doppler (CD) mode of high-frequency ultrasound was employed to assess local blood perfusion in both lesions and normal skin, while the pulsed-wave (PW) Doppler mode was used to detect the blood flow spectrum. The average of three measurements at the same site was calculated.
Time frame: The efficacy evaluation will be conducted 3 months after the completion of the 1st HMME-PDT treatment.
Plan to share: No
Ran from Mar 2024 to primary completion in Jun 2024, 3 months.
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Second Affiliated Hospital of Xi'an Jiaotong University