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NCT Number: NCT06034587

Multimodal Ultrasound Imaging Assessment on Keloid

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

multimodal ultrasound

Diagnostic Test

An Aixplorer ultrasound machine (SuperSonic Imaging, Ltd, Aixen-Provence, France), equipped with AngioPLUS(AP) and shear wave elastography(SWE) functions, was used for all examinations using a 4-15MHz linear probe.AP function can detect microvessels of lesions,SWE can evaluate the stiffness of lesions and high frequency ultrasound can measure the thickness and volume of keloid.

radioisotope applicator therapy

Radiation

The radioisotope applicator therapy utilized 90Sr-90Y(0094SR814975) isotope, customized by the China Atomic Energy Research Institute. The element therapy instrument used had overall dimensions of 2.8cm x 2.8cm, with an effective treatment area of 2.0cm x 2.0cm. It delivered a radiation dose of 5.0Gy/h. Each patient received superficial radiation therapy through a single 90Sr source, administered in repeated doses. The isotope therapy instrument was customized to fit the exact size of the keloid, ensuring coverage the irradiation range extending 0.5cm beyond the keloid's edge. During treatment, the surface of the applicator was aligned with the irradiated area and directly contact the surface of the keloid tissue. The treatment was carried out low-dose irradiation method, over 5 sessions, with each session delivering a dose of 2Gy. Each irradiation lasted for 25min.

Primary outcomes

  1. Change in stiffness measured by SWE

    Time frame: from baseline to 6 months

    The difference of stiffness in good response group and poor response group

  2. Change in microvessel signal grade measured by AP

    Time frame: from baseline to 6 months

    The difference of microvessel signal grade in good response group and poor response group

  3. Change in thickness measured by high frequency ultrasound

    Time frame: from baseline to 6 months

    The difference of thickness in good response group and poor response group

Sponsors and collaborators

Lead sponsor

Chongqing Medical University

Other

Registry information

Official study title

A Prospective, Longitudinal, Intraindividual Clinical Study in Keloid With Multimodal Ultrasound Assessment

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 13, 2023
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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