A Clinical Study on the Safety and Efficacy of Wide-Band Ultrasound Combined With Traditional Chinese Medicine Preparations in the Prevention and Treatment of Keloids (WBUS +TCM)

The prevention and treatment of patients with multiple keloids throughout the body are extremely challenging. Keloids are highly resistant, refractory, and prone to recurrence, and are thus known as the "cancer that does not kill". At present, the main clinical strategy for such patients is staged surgical resection, followed by adjuvant local radiotherapy. When signs of recurrence appear, local injection of triamcinolone acetonide plus 5-fluorouracil (5-Fu) is administered as supplementary treatment. However, these two combination therapies have obvious limitations.

Adjuvant postoperative radiotherapy is associated with a high incidence of local skin adverse reactions, including radiodermatitis and delayed wound healing. Late complications may occur weeks or months after treatment, such as permanent hyperpigmentation and hypopigmentation, skin atrophy, fibrosis, scabbing and desquamation, and intractable ulcers. In addition, radiotherapy is not suitable for some young female patients and children when keloids are located near organs such as the thyroid gland and gonads.

Injection of triamcinolone acetonide plus 5-Fu causes significant pain and requires repeated sessions. Potential risks include local ulceration, hyperpigmentation, telangiectasia, and menstrual irregularities in female patients. Therefore, there is an urgent clinical need for a pathological scar prevention and treatment technique that can rapidly relieve discomfort, promote scar atrophy, cause no secondary injury, carry low risks, have a short recovery period, provide high comfort during treatment, and be applicable to large-area or multiple pathological scars across the body.

Our research team previously observed in clinical practice that wide-band ultrasound (Universal Beauty® Type I Ultrasound Therapeutic Device) combined with traditional Chinese medicine (TCM) preparations can release abnormally accumulated and contracted collagen fibers in scar tissue via ultrasonic energy. Meanwhile, ultrasound promotes the penetration of TCM into scar lesions, exerting effects of infection control, inflammation inhibition, subsidence of redness and swelling, and relief of itching and pain.

Compared with conventional scar therapies, this approach achieves rapid symptom control, no secondary damage, no obvious side effects, a short recovery period, and high treatment comfort. It shows particularly significant advantages for large-area or multiple pathological scars throughout the body that are difficult to treat with traditional methods. Preliminary treatment in a small number of volunteers with multiple keloids has achieved satisfactory outcomes without obvious adverse reactions.

The purpose of this study is to verify the efficacy and safety of wide-band ultrasound combined with TCM preparation (Chuang Li Fu) in the prevention and treatment of keloids through this clinical trial.

Study Overview

• Status: Not yet recruiting
• Conditions: Keloid
• Intervention / Treatment: Device: Wide-Band Ultrasound; Drug: traditional Chinese medicine

Detailed Description

In this study design, surgically excised keloids were randomly assigned to 4 groups:

Blank control group (Group 0#) Ultrasound + TCM preparation group (Group 1#) Ultrasound + normal saline group (Group 2#) TCM gauze external application alone group (Group 3#) All treatments were administered once every 3 days, for a total of 10 sessions.After treatment, all keloid tissues were surgically removed and subjected to pathological examination to evaluate efficacy.

At 1 week after suture removal, all incisions received intervention with wide-band ultrasound combined with TCM preparations.Treatment was performed once every other week, for a total of 12 sessions.Subsequently, follow-up was conducted once monthly until 12 months after the last intervention.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Li Ming Li, Doctor of Philosophy; Phone Number: +86 18259061605; Email: fmulm@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

I-1 Multiple keloid lesions (≥2) on the body, requiring surgical excision and revision. The two targeted lesions shall be separated by at least 1 cm and located in the same anatomical region (e.g., abdomen, chest, upper extremity, lower leg, etc.).

I-2 Aged 14 to 60 years. I-3 The targeted keloid lesions have shown no significant spontaneous regression or continuous enlargement within the past 3-6 months,or are accompanied by obvious symptoms such as itching or pain.

I-4 Has fully understood the purpose, protocol, potential benefits, risks, countermeasures, and rights and obligations of the study (including privacy protection and voluntary withdrawal), and is willing to participate and cooperate well.

I-5 Able to understand and sign the informed consent form, and willing to comply with treatment and follow-up.

I-6 No history of allergy to any known components of the selected traditional Chinese medicine (TCM) preparation.

I-7 No prior treatment for the targeted keloid lesions within 6 months before study initiation.

Exclusion Criteria:

E-1 Currently participating in other clinical trials.E-2 Active infection or ulceration present in the targeted keloid area.E-3 Refusal to undergo surgery or biopsy for pathological confirmation.E-4 Hypertension, hypotension, or heart disease (including history of myocardial ischemia, coronary heart disease, myocarditis, etc.).E-5 Hepatic or renal insufficiency.E-6 Infectious diseases (including viral hepatitis, syphilis, AIDS, etc.).E-7 Hematological disorders (abnormal coagulation function, anemia, leukemia, polycythemia vera, aplastic anemia, etc.).E-8 Allergic constitution (urticaria, bronchial asthma, history of allergy to more than two drugs or foods).E-9 Respiratory diseases (chronic bronchitis, emphysema, bronchiectasis, pulmonary insufficiency, chronic obstructive pulmonary disease, interstitial pneumonia).E-10 Digestive system diseases (severe gastric and duodenal ulcers, chronic gastroenteritis, chronic pancreatitis).E-11 Urinary system diseases (chronic urinary tract infection, nephritis, nephrotic syndrome).E-12 Endocrine system diseases (hyperthyroidism, diabetes, acromegaly, pituitary diseases, adrenal diseases, etc.).E-13 Organic neurological diseases or mental illnesses (encephalitis, sequelae of brain trauma, epilepsy, schizophrenia, hysteria, depression, severe insomnia, neurasthenia).E-14 Chronic skin diseases (especially infectious, allergic and inflammatory systemic skin diseases, such as generalized eczema, psoriasis, pemphigus, etc.).E-15 Autoimmune diseases and collagen diseases (such as SLE, dermatomyositis, scleroderma, etc.).E-16 History of long-term smoking, alcohol abuse, or drug abuse.E-17 History of malignant tumor within the past 5 years, currently requiring other treatments such as radiotherapy and chemotherapy.E-18 Received blood transfusion or organ transplantation from others within the past 5 years.E-19 Pregnant, lactating, menstruating, or within 1 year after termination of pregnancy.E-20 Other conditions deemed unsuitable for participation in the study by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Blank control group (Group 0#); No Intervention
Experimental: Ultrasound + TCM preparation group (Group 1#); The gauze saturated with the traditional Chinese medicine (TCM) preparation was applied to the keloid lesion, followed by treatment with a wide-band ultrasound therapeutic probe placed over the gauze.	Device: Wide-Band Ultrasound; The ultrasound probe is placed over the gauze during treatment.; Drug: traditional Chinese medicine; Gauze saturated with TCM preparation is applied onto the keloid lesion
Experimental: Ultrasound + normal saline group (Group 2#); A gauze saturated with normal saline is applied to the keloid lesion, and a wide-band ultrasound therapeutic probe is then placed over the gauze to perform treatment.	Device: Wide-Band Ultrasound; The ultrasound probe is placed over the gauze during treatment.
Experimental: TCM gauze external application alone group (Group 3#); Only gauze saturated with the traditional Chinese medicine (TCM) preparation was applied to the keloid lesion for 30 minutes (the gauze was covered with plastic wrap to enhance penetration and immersion).	Drug: traditional Chinese medicine; Gauze saturated with TCM preparation is applied onto the keloid lesion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vancouver Scar Scale (VSS)	① After the first stage: the improvement in the experimental group was at least 2 points greater than that in the control group, with statistical significance.② At follow-up endpoint: no obvious hypertrophic growth in any incision scar.	up to 3 months
Patient and Observer Scar Assessment Scale (POSAS)	① At the end of Stage 1: The improvement in the experimental group was at least 6 points greater than that in the control group, with statistical significance. In addition, the three sub-items (vascularity, itching, pain) each improved by at least 2 points, with statistical significance. ② At follow-up endpoint: No obvious hypertrophic proliferation was observed in any incision scar.	up to 3 months
Scar height above the surrounding skin	① At the end of Stage 1: The scar height in the experimental group was lower than that in the control group, with statistical significance.② At follow-up endpoint: No obvious hypertrophic proliferation was observed in any incision scar.	up to 3 months
Number and proportion of scar recurrence and hypertrophy	At follow-up endpoint, incisional recurrence rate will be lower than the 20% minimum recurrence rate of postoperative radiotherapy reported in literature.	through study completion , an average 1.5 year

Collaborators and Investigators

• Sponsor: Fujian Medical University Union Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): October 31, 2028

Study Registration Dates

• First Submitted: April 6, 2026
• First Submitted That Met QC Criteria: June 25, 2026
• First Posted (Actual): July 1, 2026

Study Record Updates

• Last Update Posted (Actual): July 1, 2026
• Last Update Submitted That Met QC Criteria: June 25, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Traditional Chinese Medicine; keloid; Wide-Band Ultrasound
• Additional Relevant MeSH Terms: Pathologic Processes; Connective Tissue Diseases; Cicatrix; Fibrosis; Collagen Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Keloid; Therapeutics; Complementary Therapies; Medicine, East Asian Traditional; Medicine, Traditional; Medicine, Chinese Traditional
• Other Study ID Numbers: 2025KY744-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual patient data (IPD) will not be shared because the study does not plan to provide access to raw individual participant data to external researchers, in order to protect participant privacy, maintain data confidentiality, and comply with ethical and institutional policies.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No