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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Wound Surface Area (WSA) of patient- and investigator-selected wounds | Over 4 weeks | |
| Wound Surface Area (WSA) as a percentage of Body Surface Area (BSA) in patients with DEB | Over 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The number, severity and relationship to study procedures of adverse events (AEs) and serious AEs (SAEs) | Over 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with DEB.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ann and Robert H Lurie Childrens Hospital of Chicago | Chicago | Illinois | 60611 | United States | ||
| Columbia University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35964087 | Derived | Paller AS, Pope E, Rudin D, Malyala A, Ramsdell D, Johnson R, Landy H, Murrell DF; DEB Investigators. A prospective short-term study to evaluate methodologies for the assessment of disease extent, impact, and wound evolution in patients with dystrophic epidermolysis bullosa. Orphanet J Rare Dis. 2022 Aug 13;17(1):314. doi: 10.1186/s13023-022-02461-z. |
| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link. | View source |
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| ID | Term |
|---|---|
| D016108 | Epidermolysis Bullosa Dystrophica |
| ID | Term |
|---|---|
| D004820 | Epidermolysis Bullosa |
| D012868 | Skin Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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Optional genetic test for DEB diagnosis
| New York |
| New York |
| 10032 |
| United States |
| Cincinnati Childrens Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Premier Specialists Pty Ltd | Kogarah | 2217 | Australia |
| Salzburger Landeskliniken | Salzburg | 5020 | Austria |
| Fakultni nemocnice Brno | Brno | 613 00 | Czechia |
| Service de Génétique et INSERM UMR 1163, Laboratoire de Génétique des maladies cutanées - Institut Imagine | Paris | France |
| Universitätsklinikum Freiburg | Freiburg im Breisgau | 79104 | Germany |
| Ospedale Pediatrico Bambino Gesù | Roma | 00165 | Italy |
| Istituto Dermopatico Dell'immacolata IRCCS | Rome | 00167 | Italy |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D012872 | Skin Diseases, Vesiculobullous |