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 @ 10:53 PM
Ignite Modification Date:
2025-12-24 @ 10:53 PM
NCT ID:
NCT01716169
Eligibility Criteria:
Inclusion criteria:
1. Written consent must be obtained from subjects over age 18, or from a parent or legally authorized representative if subject is under 18. Assent will be obtained from subjects age 7 - 17.
2. Subjects with a clinical diagnosis of RDEB by a dermatologist.
3. Have at least three target wounds that meet the following criteria:
* One chronic wound, of approximately 6 months or more duration. If the subject has an additional chronic wound of similar size and duration, this additional wound will be treated with standard dressings and followed in the study. A wound in an area that consistently heals and then breaks down again will be considered a chronic wound.
* Two non-chronic wounds, of approximately 3 months or less duration, of similar size, and able to be dressed separately. Both wounds should have approximately the same duration.
All wounds must be:
* Open, and not scabbed or crusted over
* Not actively infected
* Not requiring surgical intervention
4. A parent or legally authorized representative must be willing and able to ensure subject is present for all required study visits (for minor subjects).
5. The subject or caregiver (or a parent or legally authorized representative for subjects under 18) must be able to follow instructions.
6. Subject must be age 7 or older.
Exclusion criteria:
1. Inability to travel to Stanford for study visits.
2. Complicating illness as determined by study investigators to be exclusionary including any infection requiring systemic antibiotics.
3. Presence or history of squamous cell carcinoma at target wound site.
4. Known bovine (cow) or ovine (sheep) sensitivity.
5. Therapy with an investigational agent during the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Study:
NCT01716169
Study Brief:
Protocol Section:
NCT01716169