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

Epidermolysis Bullosa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01716169
• Other study ID #: 24915
• Status: Completed
• Phase: N/A
• First received: October 25, 2012
• Last updated: March 27, 2014
• Start date: October 2012
• Est. completion date: November 2013

Study information

• Verified date: March 2014
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years and older

Eligibility

Inclusion criteria:

1. 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.

2. Subjects with a clinical diagnosis of RDEB by a dermatologist.

3. 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

4. A parent or legally authorized representative must be willing and able to ensure subject is present for all required study visits (for minor subjects).

5. The subject or caregiver (or a parent or legally authorized representative for subjects under 18) must be able to follow instructions.

6. Subject must be age 7 or older.

Exclusion criteria:

1. Inability to travel to Stanford for study visits.

2. Complicating illness as determined by study investigators to be exclusionary including any infection requiring systemic antibiotics.

3. Presence or history of squamous cell carcinoma at target wound site.

4. Known bovine (cow) or ovine (sheep) sensitivity.

5. Therapy with an investigational agent during the study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epidermolysis Bullosa
• Epidermolysis Bullosa Dystrophica

Intervention

Device:
• Helicoll
Helicoll Collagen I Wound Dressing
• Standard of Care Dressings
Standard of Care wound dressings (e.g. Vaseline gauze)

Locations

Country	Name	City	State
United States	Stanford School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of wounds achieving 100% re-epithelialization at Week 8		Week 8	No