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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:
ClinicalTrials.gov Identifier:
NCT01716169
First Posted: October 29, 2012
Last Update Posted: May 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alfred Lane, Stanford University
  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: Intervention Model: Single Group Assignment
Masking: None (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 Alfred Lane, Stanford University:

Primary Outcome Measures:
  • Percentage of Wound Surface Area Change From Baseline to Week 8 [ Time Frame: 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.


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

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Alfred Lane, Professor of Dermatology and Pediatrics, Stanford University
ClinicalTrials.gov Identifier: NCT01716169     History of Changes
Other Study ID Numbers: 24915
First Submitted: October 25, 2012
First Posted: October 29, 2012
Results First Submitted: May 22, 2015
Results First Posted: May 5, 2016
Last Update Posted: May 5, 2016
Last Verified: April 2016

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