Clinical trial NCT06034587: Multimodal Ultrasound Imaging Assessment on Keloid
Official title: A Prospective, Longitudinal, Intraindividual Clinical Study in Keloid With Multimodal Ultrasound Assessment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Keloid
Keywords: multimodal ultrasound
shear wave elastography
microvessel imaging
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 34
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 34 outpatients (mean age 43 ± 10.4 years, 14 male, 20 female) with untreated 63 keloids in different anatomical locations and 63 corresponding normal skin sites was performed

Brief summary: Skin keloids are common dermatological conditions that can lead to physical limitations, functional impairments, and deformities. Beyond the physiological implications, the aesthetic ramifications of keloids can also result in significant psychological distress, including anxiety and depression, causing both physical and emotional suffering to the affected individuals. The incidence of keloids is high, characterized by their chronicity, resistance to treatment, and high recurrence rate. They have become one of the most challenging conditions to treat across burn surgery, plastic surgery, and dermatology disciplines. The lack of standardized clinical treatment guidelines globally, combined with an absence of a well-defined standardized evaluation system, means that the effectiveness of various treatments is not consistently and objectively assessed, creating significant challenges in clinical applications. This project integrates traditional high-frequency ultrasound with cutting-edge technologies like real-time shear wave elastography and ultra-micro blood flow imaging. By using multimodal ultrasound, investigators aim to observe the therapeutic response of 90Sr-90Y patch treatment on skin keloids. Investigators seek to determine the objectivity and quantification role of multimodal ultrasound data and indicators in assessing keloid severity, including blood flow information and elasticity hardness. Another goal is to obtain quantitative data on keloid thickness, volume, stiffness, and microvascular distribution before and after treatment to monitor the therapy response. This would address the current limitations of subjective keloid scoring scales. It would also serve as an objective assessment standard for precise diagnosis, treatment, and follow-up of keloids in a clinical setting, thereby standardizing the clinical diagnosis and treatment of keloids.

Detailed description: Currently, no one-size-fits-all approach exists and a universally accepted, standardized evaluation and treatment protocol remains elusive, making it challenging to determine which method is the most effective. Commonly used methods for assessing keloids, such as the Vancouver Scar Scale (VSS) and the Patient and Observer Scar Assessment Scale (POSAS), rely heavily on subjective evaluations based on observer perception and patient-reported experiences. These methods lack objective quantitative evaluation indicators and the ability to visualize subcutaneous tissues, limiting their individual clinical applicability. The Vancouver Scar Scale (VSS) is the most established questionnaire used for the evaluation of pathological scarring. This scale evaluates aspects of scar vascularity, pigmentation, pliability, and height, with the scoring system ranging from 0 to 15, where 0 is the least severe and 15 is the most severe. In the study, keloids were classified into three categories based on the VSS score: mild (0-5), moderate (6-9), and severe (10-15).

Eligibility criteria: Inclusion Criteria:

* Male and female patients aged 16 years and above
* Outpatients with no received any treatment in previous 6 months
* Willing to participate in this trial and have signed an informed consent form

Exclusion Criteria:

* Pregnant or breastfeeding women
* patients with malignant tumors, hypertension, diabetes, skin rupture, skin infection which may influence keloid healing and other dermatologic diseases

Primary outcomes:
measure: Change in stiffness measured by SWE
timeFrame: from baseline to 6 months
measure: Change in microvessel signal grade measured by AP
timeFrame: from baseline to 6 months
measure: Change in thickness measured by high frequency ultrasound
timeFrame: from baseline to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: Chongqing Medical University
name: Wang Zhigang
role: STUDY_CHAIR
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