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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alfred Lane, Stanford University
ClinicalTrials.gov Identifier:
NCT01716169
First received: October 25, 2012
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Epidermolysis Bullosa Dystrophica
Epidermolysis Bullosa
Device: Helicoll
Device: Standard of Care Dressings

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Chronic and Non-Chronic Wounds in Patients With Recessive Dystrophic Epidermolysis Bullosa Using Helicoll Collagen Dressings Versus Standard of Care

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Proportion of wounds achieving 100% re-epithelialization at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: October 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Helicoll - Chronic Wound
Helicoll will be applied to one chronic wound (approximately 6 months or more duration)
Device: Helicoll
Helicoll Collagen I Wound Dressing
Experimental: Helicoll - Non-Chronic Wound
Helicoll will be applied to one non-chronic wound (approximately 3 months or less in duration).
Device: Helicoll
Helicoll Collagen I Wound Dressing
Active Comparator: Standard of Care - Non-Chronic Wound
Standard of Care wound dressings (e.g. Vaseline gauze) will be applied to one non-chronic wound (of approximately 3 months duration).
Device: Standard of Care Dressings
Standard of Care wound dressings (e.g. Vaseline gauze)
Active Comparator: 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 subject has more than one chronic wound of approximately the same size and duration.
Device: Standard of Care Dressings
Standard of Care wound dressings (e.g. Vaseline gauze)

  Eligibility

Ages Eligible for Study:   7 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01716169

Locations
United States, California
Stanford School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Alfred Lane, MD Stanford University
  More Information

No publications provided

Responsible Party: Alfred Lane, Professor of Dermatology and Pediatrics, Stanford University
ClinicalTrials.gov Identifier: NCT01716169     History of Changes
Other Study ID Numbers: 24915
Study First Received: October 25, 2012
Last Updated: March 27, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Epidermolysis Bullosa
Epidermolysis Bullosa Dystrophica
Collagen Diseases
Congenital Abnormalities
Connective Tissue Diseases
Genetic Diseases, Inborn
Skin Abnormalities
Skin Diseases
Skin Diseases, Genetic
Skin Diseases, Vesiculobullous

ClinicalTrials.gov processed this record on November 20, 2014