Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-24 @ 6:37 PM
NCT ID:
NCT06913257
Eligibility Criteria:
Inclusion Criteria:
Adults aged 18-65 years. Documented hypertrophic scars following a burn injury, with scars present and stable for at least 6 months.
Moderate to severe scar severity as measured by a standardized clinical assessment.
Experiencing significant pain and/or pruritus related to the scar, with a baseline VAS score of ≥4.
Able to provide informed consent and comply with study procedures. Employed or engaged in daily activities such that indirect costs (absenteeism/reduced productivity) can be recorded.
Exclusion Criteria:
Pregnant or lactating women. Individuals with previous surgical scar revision or other invasive scar treatments within the last 6 months.
Patients with comorbid conditions (e.g., severe cardiovascular disease, uncontrolled diabetes) that could interfere with rehabilitation or ESWT.
Active skin infection in the area of the scar. Use of concurrent investigational therapies for scar management.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06913257
Study Brief:
Protocol Section:
NCT06913257