Treatment of Chronic and Non-Chronic Wounds in Patients With Recessive Dystrophic Epidermolysis Bullosa Using Helicoll Collagen Dressings Versus Standard of Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Percentage of Wound Surface Area Change From Baseline to Week 8
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written consent must be obtained from subjects over age 18, or from a parent or legally authorized representative if subject is under
- •Assent will be obtained from subjects age 7 -
- •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.
排除标准
- •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.
研究组 & 干预措施
Helicoll
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.
干预措施: Helicoll (Device)
Helicoll
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.
干预措施: Standard of Care Dressings (Device)
结局指标
主要结局
Percentage of Wound Surface Area Change From Baseline to Week 8
时间窗: Baseline and 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.
次要结局
未报告次要终点
研究者
Alfred Lane
Professor of Dermatology and Pediatrics
Stanford University