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

NCT ID: NCT01716169

Last Updated: 2016-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-11-30

Brief 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.

Conditions

Epidermolysis Bullosa Dystrophica; Epidermolysis Bullosa

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Helicoll

Intervention Type: DEVICE

Helicoll Collagen I Wound Dressing

Standard of Care Dressings

Intervention Type: DEVICE

Standard of Care wound dressings (e.g. Vaseline gauze)

Interventions

Helicoll

Helicoll Collagen I Wound Dressing

Intervention Type: DEVICE

Standard of Care Dressings

Standard of Care wound dressings (e.g. Vaseline gauze)

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Alfred Lane

Professor of Dermatology and Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alfred Lane, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford School of Medicine

Stanford, California, United States

Countries

United States

Other Identifiers

24915

Identifier Type: -

Identifier Source: org_study_id