Treatment of Chronic and Non-Chronic Wounds in Patients With Recessive Dystrophic Epidermolysis Bullosa Using Helicoll Collagen Dressings Versus Standard of Care
|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.|
|ClinicalTrials.gov Identifier: NCT01716169|
Recruitment Status : Completed
First Posted : October 29, 2012
Results First Posted : May 5, 2016
Last Update Posted : May 5, 2016
|Condition or disease||Intervention/treatment||Phase|
|Epidermolysis Bullosa Dystrophica Epidermolysis Bullosa||Device: Helicoll Device: Standard of Care Dressings||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Chronic and Non-Chronic Wounds in Patients With Recessive Dystrophic Epidermolysis Bullosa Using Helicoll Collagen Dressings Versus Standard of Care|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2013|
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.
Helicoll Collagen I Wound DressingDevice: Standard of Care Dressings
Standard of Care wound dressings (e.g. Vaseline gauze)
- 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.
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
|United States, California|
|Stanford School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Alfred Lane, MD||Stanford University|