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 @ 7:59 PM
Ignite Modification Date:
2025-12-24 @ 7:59 PM
NCT ID:
NCT01040104
Eligibility Criteria:
WP2.1
Inclusion Criteria:
* age 18-45 and 55-85 years, respectively
Exclusion Criteria:
* past medical history of hypertrophic scarring or keloid disease
* cardiac disease adversely affecting peripheral blood flow
* active neoplastic disease
* immunosuppressive condition, congenital or acquired
* anemia
* autoimmune disorder
* acute or chronic renal failure
* liver cirrhosis or active hepatitis
* active substance-abuse disorder
* severe underweight (body mass index \<16)
* endocrinological disorder
* pregnancy or lactation for women of child-bearing age
WP2.2
Inclusion Criteria:
* age 18-45 and 55-85 years, respectively
* normal and/or hypertrophic scars
* Baux score \<100
Exclusion Criteria:
* sepsis
* electrical and/or chemical burn
* clinically significant wound infection in areas of planned biopsies
* cardiac disease adversely affecting peripheral blood flow
* active neoplastic disease
* immunosuppressive condition, congenital or acquired
* autoimmune disorder
* acute or chronic renal failure
* liver cirrhosis or active hepatitis
* active substance-abuse disorder
* severe underweight (body mass index \<16)
* endocrinological disorder
* pregnancy or lactation for women of child-bearing age
WP 2.4
Inclusion Criteria:
* age 18-45 and 55-85 years, respectively
Exclusion Criteria:
* cardiac disease adversely affecting peripheral blood flow
* active neoplastic disease
* immunosuppressive condition, congenital or acquired
* anemia
* autoimmune disorder
* acute or chronic renal failure
* liver cirrhosis or active hepatitis
* substance-abuse disorder
* severe underweight (body mass index \<16)
* thyroid function disorder
* pregnancy or lactation for women of child-bearing age
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT01040104
Study Brief:
Protocol Section:
NCT01040104