KeloidNCT06034587
Multimodal Ultrasound Imaging Assessment on Keloid
An observational study of Keloid, run by Chongqing Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Keloid
- What is being tested?
- multimodal ultrasound and radioisotope applicator therapy
- Type of treatment
- Surgery or procedure
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 21 Jul 2021to 30 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Pregnant or breastfeeding women
- patients with malignant tumors, hypertension, diabetes, skin rupture, skin infection which may influence keloid healing and other dermatologic diseases
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
About this study
Official title: A Prospective, Longitudinal, Intraindividual Clinical Study in Keloid With Multimodal Ultrasound Assessment
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.
Read the 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).
- Conditions
- Keloid
- Being tested
- multimodal ultrasound, radioisotope applicator therapy
- Keywords
- multimodal ultrasound, shear wave elastography, microvessel imaging
- Medical subject headings
- Keloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multimodal ultrasoundDiagnostic 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 therapyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| good response group of treated keloids | 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.All the keloids in the study were classified into three categories based on the VSS score: mild (0-5), moderate (6-9), and severe (10-15).
For treatment assessment, investigators further divided the treated participants into two groups: a good response group (showing an improvement of 5 or more points in the VSS score) and a poor response group (less than 5 points improvement in the VSS score) Receives: Diagnostic Test: multimodal ultrasound; Radiation: radioisotope applicator therapy | |
| poor response group of treated keloids | 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. All the keloids in the study keloids were classified into three categories based on the VSS score: mild (0-5), moderate (6-9), and severe(10-15).
For treatment assessment, investigators further divided the treated participants into two groups: a good response group (showing an improvement of 5 or more points in the VSS score) and a poor response group (less than 5 points improvement in the VSS score) Receives: Diagnostic Test: multimodal ultrasound; Radiation: radioisotope applicator therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in stiffness measured by SWE
The difference of stiffness in good response group and poor response group
Measured: from baseline to 6 months
Change in microvessel signal grade measured by AP
The difference of microvessel signal grade in good response group and poor response group
Measured: from baseline to 6 months
Change in thickness measured by high frequency ultrasound
The difference of thickness in good response group and poor response group
Measured: from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start21 Jul 2021
- Primary completion30 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for KeloidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Zhigang, Chongqing Medical University
- Investigators
- Wang Zhigang, Study chair, Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06034587
- Sponsor's protocol ID
- CQMUSAZL0619
- Status last verified
- Sep 2023
- First submitted
- 5 Sep 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dirrichs T, Quack V, Gatz M, Tingart M, Rath B, Betsch M, Kuhl CK, Schrading S. Shear Wave Elastography (SWE) for Monitoring of Treatment of Tendinopathies: A Double-blinded, Longitudinal Clinical Study. Acad Radiol. 2018 Mar;25(3):265-272. doi: 10.1016/j.acra.2017.09.011. Epub 2017 Nov 16.
PubMed 29153963DeJong H, Abbott S, Zelesco M, Spilsbury K, Ziman M, Kennedy BF, Martin L, Wood FM. Objective quantification of burn scar stiffness using shear-wave elastography: Initial evidence of validity. Burns. 2020 Dec;46(8):1787-1798. doi: 10.1016/j.burns.2020.05.009. Epub 2020 May 19.
PubMed 32534890Schwaiger H, Reinholz M, Poetschke J, Ruzicka T, Gauglitz G. Evaluating the Therapeutic Success of Keloids Treated With Cryotherapy and Intralesional Corticosteroids Using Noninvasive Objective Measures. Dermatol Surg. 2018 May;44(5):635-644. doi: 10.1097/DSS.0000000000001427.
PubMed 29701618Nast A, Gauglitz G, Lorenz K, Metelmann HR, Paasch U, Strnad V, Weidmann M, Werner RN, Bauerschmitz J. S2k guidelines for the therapy of pathological scars (hypertrophic scars and keloids) - Update 2020. J Dtsch Dermatol Ges. 2021 Feb;19(2):312-327. doi: 10.1111/ddg.14279. Epub 2020 Oct 4. No abstract available.
PubMed 33015930Yang Y, Wang L, Yan F, Xiang X, Tang Y, Zhang L, Liu J, Qiu L. Determination of Normal Skin Elasticity by Using Real-time Shear Wave Elastography. J Ultrasound Med. 2018 Nov;37(11):2507-2516. doi: 10.1002/jum.14608. Epub 2018 Mar 25.
PubMed 29575120Yang Y, Qiu L, Wang L, Xiang X, Tang Y, Li H, Yan F. Quantitative Assessment of Skin Stiffness Using Ultrasound Shear Wave Elastography in Systemic Sclerosis. Ultrasound Med Biol. 2019 Apr;45(4):902-912. doi: 10.1016/j.ultrasmedbio.2018.11.015. Epub 2019 Jan 18.
PubMed 30665723Tsai WY, Hsueh YY, Chen PY, Hung KS, Huang CC. High-Frequency Ultrasound Elastography for Assessing Elastic Properties of Skin and Scars. IEEE Trans Ultrason Ferroelectr Freq Control. 2022 Jun;69(6):1871-1880. doi: 10.1109/TUFFC.2022.3154235. Epub 2022 May 26.
PubMed 35201987Guo R, Xiang X, Wang L, Zhu B, Cheng S, Qiu L. Quantitative Assessment of Keloids Using Ultrasound Shear Wave Elastography. Ultrasound Med Biol. 2020 May;46(5):1169-1178. doi: 10.1016/j.ultrasmedbio.2020.01.010. Epub 2020 Feb 13.
PubMed 32063394Reinholz M, Schwaiger H, Poetschke J, Epple A, Ruzicka T, Von Braunmuhl T, Gauglitz GG. Objective and subjective treatment evaluation of scars using optical coherence tomography, sonography, photography, and standardised questionnaires. Eur J Dermatol. 2016 Dec 1;26(6):599-608. doi: 10.1684/ejd.2016.2873.
PubMed 27762215Elrefaie AM, Salem RM, Faheem MH. High-resolution ultrasound for keloids and hypertrophic scar assessment. Lasers Med Sci. 2020 Mar;35(2):379-385. doi: 10.1007/s10103-019-02830-4. Epub 2019 Jun 25.
PubMed 31240510DeJong H, Abbott S, Zelesco M, Spilsbury K, Martin L, Sanderson R, Ziman M, Kennedy BF, Wood FM. A Novel, Reliable Protocol to Objectively Assess Scar Stiffness Using Shear Wave Elastography. Ultrasound Med Biol. 2020 Jul;46(7):1614-1629. doi: 10.1016/j.ultrasmedbio.2020.03.003. Epub 2020 May 5.
PubMed 32386847Xu C, Ting W, Teng Y, Long X, Wang X. Laser Speckle Contrast Imaging for the Objective Assessment of Blood Perfusion in Keloids Treated With Dual-Wavelength Laser Therapy. Dermatol Surg. 2021 Apr 1;47(4):e117-e121. doi: 10.1097/DSS.0000000000002836.
PubMed 33795568Son Y, Phillips EON, Price KM, Rosenberg LZ, Stefanovic B, Wolfe CM, Shaath TS, Om A, Cohen GF, Gunjan A. Treatment of keloids with a single dose of low-energy superficial X-ray radiation to prevent recurrence after surgical excision: An in vitro and in vivo study. J Am Acad Dermatol. 2020 Nov;83(5):1304-1314. doi: 10.1016/j.jaad.2020.06.023. Epub 2020 Jun 12.
PubMed 32540415Tang Y, Cheng S, Tang X, Guo R, Zhang L, Qiu L. Quantification of skin lesions using high-frequency ultrasound and shear wave elastography in port-wine stain patients: a clinical study. Ann Transl Med. 2019 Dec;7(24):803. doi: 10.21037/atm.2019.12.57.
PubMed 32042819Xiang X, Yan F, Yang Y, Tang Y, Wang L, Zeng J, Qiu L. Quantitative Assessment of Healthy Skin Elasticity: Reliability and Feasibility of Shear Wave Elastography. Ultrasound Med Biol. 2017 Feb;43(2):445-452. doi: 10.1016/j.ultrasmedbio.2016.10.002. Epub 2016 Dec 2.
PubMed 27919522
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Longitudinal, Intraindividual Clinical Study in Keloid With Multimodal Ultrasound Assessment
- ClinicalTrials.gov ID
- NCT06034587
- Acronym / sponsor ID
- CQMUSAZL0619
- Conditions
- Keloid
- Keywords
- multimodal ultrasound, shear wave elastography, microvessel imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 21 Jul 2021 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| good response group of treated keloids | – | Diagnostic Test: multimodal ultrasound, Radiation: radioisotope applicator therapyThe 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.All the keloids in the study were classified into three categories based on the VSS score: mild (0-5), moderate (6-9), and severe (10-15). For treatment assessment, investigators further divided the treated participants into two groups: a good response group (showing an improvement of 5 or more points in the VSS score) and a poor response group (less than 5 points improvement in the VSS score) |
| poor response group of treated keloids | – | Diagnostic Test: multimodal ultrasound, Radiation: radioisotope applicator therapyThe 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. All the keloids in the study keloids were classified into three categories based on the VSS score: mild (0-5), moderate (6-9), and severe(10-15). For treatment assessment, investigators further divided the treated participants into two groups: a good response group (showing an improvement of 5 or more points in the VSS score) and a poor response group (less than 5 points improvement in the VSS score) |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnant or breastfeeding women
- patients with malignant tumors, hypertension, diabetes, skin rupture, skin infection which may influence keloid healing and other dermatologic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multimodal ultrasoundAn 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. | Diagnostic test | good response group of treated keloids, poor response group of treated keloids |
| radioisotope applicator therapyThe 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. | Radiation | good response group of treated keloids, poor response group of treated keloids |
Primary outcome
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Background: PubMed 29153963Dirrichs T, Quack V, Gatz M, Tingart M, Rath B, Betsch M, Kuhl CK, Schrading S. Shear Wave Elastography (SWE) for Monitoring of Treatment of Tendinopathies: A Double-blinded, Longitudinal Clinical Study. Acad Radiol. 2018 Mar;25(3):265-272. doi: 10.1016/j.acra.2017.09.011. Epub 2017 Nov 16.
- Results publication: PubMed 32534890DeJong H, Abbott S, Zelesco M, Spilsbury K, Ziman M, Kennedy BF, Martin L, Wood FM. Objective quantification of burn scar stiffness using shear-wave elastography: Initial evidence of validity. Burns. 2020 Dec;46(8):1787-1798. doi: 10.1016/j.burns.2020.05.009. Epub 2020 May 19.
- Results publication: PubMed 29701618Schwaiger H, Reinholz M, Poetschke J, Ruzicka T, Gauglitz G. Evaluating the Therapeutic Success of Keloids Treated With Cryotherapy and Intralesional Corticosteroids Using Noninvasive Objective Measures. Dermatol Surg. 2018 May;44(5):635-644. doi: 10.1097/DSS.0000000000001427.
- Results publication: PubMed 33015930Nast A, Gauglitz G, Lorenz K, Metelmann HR, Paasch U, Strnad V, Weidmann M, Werner RN, Bauerschmitz J. S2k guidelines for the therapy of pathological scars (hypertrophic scars and keloids) - Update 2020. J Dtsch Dermatol Ges. 2021 Feb;19(2):312-327. doi: 10.1111/ddg.14279. Epub 2020 Oct 4. No abstract available.
- Results publication: PubMed 29575120Yang Y, Wang L, Yan F, Xiang X, Tang Y, Zhang L, Liu J, Qiu L. Determination of Normal Skin Elasticity by Using Real-time Shear Wave Elastography. J Ultrasound Med. 2018 Nov;37(11):2507-2516. doi: 10.1002/jum.14608. Epub 2018 Mar 25.
- Results publication: PubMed 30665723Yang Y, Qiu L, Wang L, Xiang X, Tang Y, Li H, Yan F. Quantitative Assessment of Skin Stiffness Using Ultrasound Shear Wave Elastography in Systemic Sclerosis. Ultrasound Med Biol. 2019 Apr;45(4):902-912. doi: 10.1016/j.ultrasmedbio.2018.11.015. Epub 2019 Jan 18.
- Results publication: PubMed 35201987Tsai WY, Hsueh YY, Chen PY, Hung KS, Huang CC. High-Frequency Ultrasound Elastography for Assessing Elastic Properties of Skin and Scars. IEEE Trans Ultrason Ferroelectr Freq Control. 2022 Jun;69(6):1871-1880. doi: 10.1109/TUFFC.2022.3154235. Epub 2022 May 26.
- Results publication: PubMed 32063394Guo R, Xiang X, Wang L, Zhu B, Cheng S, Qiu L. Quantitative Assessment of Keloids Using Ultrasound Shear Wave Elastography. Ultrasound Med Biol. 2020 May;46(5):1169-1178. doi: 10.1016/j.ultrasmedbio.2020.01.010. Epub 2020 Feb 13.
- Results publication: PubMed 27762215Reinholz M, Schwaiger H, Poetschke J, Epple A, Ruzicka T, Von Braunmuhl T, Gauglitz GG. Objective and subjective treatment evaluation of scars using optical coherence tomography, sonography, photography, and standardised questionnaires. Eur J Dermatol. 2016 Dec 1;26(6):599-608. doi: 10.1684/ejd.2016.2873.
- Results publication: PubMed 31240510Elrefaie AM, Salem RM, Faheem MH. High-resolution ultrasound for keloids and hypertrophic scar assessment. Lasers Med Sci. 2020 Mar;35(2):379-385. doi: 10.1007/s10103-019-02830-4. Epub 2019 Jun 25.
- Results publication: PubMed 32386847DeJong H, Abbott S, Zelesco M, Spilsbury K, Martin L, Sanderson R, Ziman M, Kennedy BF, Wood FM. A Novel, Reliable Protocol to Objectively Assess Scar Stiffness Using Shear Wave Elastography. Ultrasound Med Biol. 2020 Jul;46(7):1614-1629. doi: 10.1016/j.ultrasmedbio.2020.03.003. Epub 2020 May 5.
- Results publication: PubMed 33795568Xu C, Ting W, Teng Y, Long X, Wang X. Laser Speckle Contrast Imaging for the Objective Assessment of Blood Perfusion in Keloids Treated With Dual-Wavelength Laser Therapy. Dermatol Surg. 2021 Apr 1;47(4):e117-e121. doi: 10.1097/DSS.0000000000002836.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wang Zhigang study chair
Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Keloid, run by Chongqing Medical 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 2 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: finished, as of the sponsor's last update on 13 Sep 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in stiffness measured by SWE (time frame: from baseline to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06034587, which also lists 17 linked publications.
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 13 Sep 2023.