Short Term Observational Study in DEB Patients



Status:Completed
Conditions:Skin and Soft Tissue Infections, Skin and Soft Tissue Infections
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:Any
Updated:2/8/2015
Start Date:June 2014
End Date:February 2015

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A Prospective Short-term Study to Evaluate Methodologies for the Assessment of Disease Extent, Impact, and Wound Evolution in Patients With Dystrophic Epidermolysis Bullosa (DEB)

The purpose of this study is to better understand disease extent and to identify appropriate
methodologies to evaluate (dystrophic epidermolysis bullosa) DEB in a quantitative and
qualitative manner.


Inclusion Criteria:

1. Written informed consent is provided. Patients 18 years of age and older, and
parent(s)/legal guardian(s) of patients younger than 18 years of age, must provide
written informed consent prior to participating in the study; additionally, informed
assent will be obtained from patients younger than 18 years of age as specified by
local requirements.

2. Patient must have a documented diagnosis of DEB based on genetic analysis showing a
mutation in COL7A1 or, in the opinion of the investigator, a confirmed diagnosis of
DEB based on histologic criteria (antigen mapping or electron microscopy).

3. Patient must have at least 5 wounds that are suitable for imaging, in the opinion of
the investigator, at the time of enrollment.

4. Patient is willing and able to undergo the protocol-specified procedures.

Exclusion Criteria:

1. Patient has used or is currently using experimental treatment for DEB including, but
not limited to, bone marrow transplantation, systemic immune suppression, or
experimental procedures that involve live cells, with potential for systemic spread
such as gene transfer, stem cell infusions, or other cell type injections such that,
in the opinion of the investigator, inclusion poses an unacceptable risk to the
patient or interpretation of these study data.

2. Patient has squamous cell carcinoma with evidence of locally invasive disease or
distant metastases.

3. Patient is pregnant.
We found this trial at
3
sites
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Cincinnati, OH
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225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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Chicago, IL
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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New York, NY
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