Treatment of Chronic and Non-Chronic Wounds in Patients With Recessive Dystrophic Epidermolysis Bullosa Using Helicoll Collagen Dressings Versus Standard of Care

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.