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Trial record 14 of 29 for:    "Epidermolysis Bullosa Dystrophica" OR "dystrophic epidermolysis bullosa"

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
Sponsor:
Information provided by (Responsible Party):
Alfred Lane, Stanford University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Epidermolysis Bullosa Dystrophica
Epidermolysis Bullosa
Interventions: Device: Helicoll
Device: Standard of Care Dressings

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment from EB Clinic patients, organization website

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Helicoll - Chronic Wound

Helicoll will be applied to one chronic wound (approximately 6 months or more duration)

Helicoll: Helicoll Collagen I Wound Dressing


Participant Flow:   Overall Study
    Helicoll - Chronic Wound
STARTED   10 
Standard of Care Dressings Used   7 
COMPLETED   6 
NOT COMPLETED   4 
Adverse Event                1 
Lost to Follow-up                1 
Withdrawal by Subject                1 
inconsistent dressing application                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Helicoll - Chronic Wound

Helicoll will be applied to one chronic wound (approximately 6 months or more duration)

Helicoll: Helicoll Collagen I Wound Dressing


Baseline Measures
   Helicoll - Chronic Wound 
Overall Participants Analyzed 
[Units: Participants]
 10 
Age 
[Units: Participants]
 
<=18 years   8 
Between 18 and 65 years   2 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 15.6  (5.6) 
Gender 
[Units: Participants]
 
Female   5 
Male   5 
Region of Enrollment 
[Units: Participants]
 
United States   10 


  Outcome Measures

1.  Primary:   Percentage of Wound Surface Area Change From Baseline to Week 8   [ Time Frame: Baseline and Week 8 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Alfred Lane
Organization: Stanford School of Medicine
phone: 650 721 7166
e-mail: atlane@stanford.edu



Responsible Party: Alfred Lane, 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