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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

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ClinicalTrials.gov Identifier: NCT01716169
Recruitment Status : Completed
First Posted : October 29, 2012
Results First Posted : May 5, 2016
Last Update Posted : May 5, 2016
Sponsor:
Information provided by (Responsible Party):
Alfred Lane, Stanford University

October 25, 2012
October 29, 2012
May 22, 2015
May 5, 2016
May 5, 2016
October 2012
November 2013   (Final data collection date for primary outcome measure)
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.
Proportion of wounds achieving 100% re-epithelialization at Week 8 [ Time Frame: Week 8 ]
Complete list of historical versions of study NCT01716169 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Not Provided
 
Treatment of Chronic and Non-Chronic Wounds in Patients With Recessive Dystrophic Epidermolysis Bullosa Using Helicoll Collagen Dressings Versus Standard of Care
Treatment of Chronic and Non-Chronic Wounds in Patients With Recessive Dystrophic Epidermolysis Bullosa Using Helicoll Collagen Dressings Versus Standard of Care
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.
Not Provided
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Epidermolysis Bullosa Dystrophica
  • Epidermolysis Bullosa
  • Device: Helicoll
    Helicoll Collagen I Wound Dressing
  • Device: Standard of Care Dressings
    Standard of Care wound dressings (e.g. Vaseline gauze)
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.

Interventions:
  • Device: Helicoll
  • Device: Standard of Care Dressings
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
Same as current
November 2013
November 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
7 Years and older   (Child, Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01716169
24915
No
Not Provided
Not Provided
Alfred Lane, Stanford University
Stanford University
Not Provided
Principal Investigator: Alfred Lane, MD Stanford University
Stanford University
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP