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The purpose of this study is to test the effectiveness of Helicoll (a collagen wound dressing) in treating chronic and non-chronic wounds of recessive dystrophic epidermolysis bullosa (RDEB) patients. Helicoll will be compared to standard wound dressings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Helicoll | Experimental | Helicoll will be applied to one chronic wound (approximately 6 months or more duration). Wound designations of "control" or "Helicoll" were placed in a sealed envelope prior to study start. When a subject was enrolled, wounds were identified as "A" or "B". Then the envelope was opened which designated whether A or B would receive control or Helicoll. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Helicoll | Device | Helicoll Collagen I Wound Dressing |
| |
| Standard of Care Dressings |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Wound Surface Area Change From Baseline to Week 8 | Change was assessed in terms of wound surface area, as measured using the ARANZ camera. Week 8 surface area measurement was compared to baseline surface area measurement and percentage in size change was calculated. | Baseline and Week 8 |
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Inclusion criteria:
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.
Subjects with a clinical diagnosis of RDEB by a dermatologist.
Have at least three target wounds that meet the following criteria:
All wounds must be:
A parent or legally authorized representative must be willing and able to ensure subject is present for all required study visits (for minor subjects).
The subject or caregiver (or a parent or legally authorized representative for subjects under 18) must be able to follow instructions.
Subject must be age 7 or older.
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alfred Lane, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford School of Medicine | Stanford | California | 94305 | United States |
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Recruitment from EB Clinic patients, organization website
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| ID | Title | Description |
|---|---|---|
| FG000 | Helicoll - Chronic Wound | Helicoll will be applied to one chronic wound (approximately 6 months or more duration) Helicoll: Helicoll Collagen I Wound Dressing |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Device |
Standard of Care wound dressings (e.g. Vaseline gauze) |
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| Standard of Care Dressings Used |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Helicoll - Chronic Wound | Helicoll will be applied to one chronic wound (approximately 6 months or more duration) Helicoll: Helicoll Collagen I Wound Dressing |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Wound Surface Area Change From Baseline to Week 8 | Change was assessed in terms of wound surface area, as measured using the ARANZ camera. Week 8 surface area measurement was compared to baseline surface area measurement and percentage in size change was calculated. | Posted | Mean | 95% Confidence Interval | percentage of wound surface area | Baseline and Week 8 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Helicoll - Chronic Wound | Helicoll will be applied to one chronic wound (approximately 6 months or more duration) Helicoll: Helicoll Collagen I Wound Dressing | 0 | 10 | 1 | 10 | ||
| EG001 | Standard of Care - Chronic Wound | Standard of Care wound dressings (e.g. Vaseline gauze) will be applied to one chronic wound (of approximately 6 months duration) if the subject has more than one chronic wound of approximately the same size and duration as Helicoll chronic wound. | 0 | 7 | 0 | 7 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| wound infection | Infections and infestations |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alfred Lane | Stanford School of Medicine | 650 721 7166 | atlane@stanford.edu |
| ID | Term |
|---|---|
| D016108 | Epidermolysis Bullosa Dystrophica |
| D004820 | Epidermolysis Bullosa |
| ID | Term |
|---|---|
| D012868 | Skin Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| 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 |
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