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

Study Overview
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Brief Summary
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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.

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

Conditions
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Epidermolysis Bullosa Dystrophica, Epidermolysis Bullosa

Intervention / Treatment
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* Device: Helicoll
* Device: Standard of Care Dressings


Participation Criteria
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Eligibility Criteria
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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: 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 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: Inability to travel to Stanford for study visits. Complicating illness as determined by study investigators to be exclusionary including any infection requiring systemic antibiotics. Presence or history of squamous cell carcinoma at target wound site. Known bovine (cow) or ovine (sheep) sensitivity. Therapy with an investigational agent during the study.

Ages Eligible for Study
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Minimum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Helicoll<br>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. | Device: Helicoll<br>* Helicoll Collagen I Wound Dressing<br>Device: Standard of Care Dressings<br>* Standard of Care wound dressings (e.g. Vaseline gauze)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |