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Vascular Malformations and Abnormalities of Growth

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: NCT01105676
Recruitment Status : Completed
First Posted : April 16, 2010
Last Update Posted : January 7, 2014
Children's Research Institute
Information provided by (Responsible Party):
Beth Drolet, Medical College of Wisconsin

April 15, 2010
April 16, 2010
January 7, 2014
November 2008
December 2013   (Final data collection date for primary outcome measure)
Percent of growth over time [ Time Frame: 5 years ]
Same as current
Complete list of historical versions of study NCT01105676 on ClinicalTrials.gov Archive Site
Patient specific gene and protein expression levels that can distinguish affected from unaffected tissue in patients. [ Time Frame: 5 years ]
Same as current
Not Provided
Not Provided
Vascular Malformations and Abnormalities of Growth
Vascular Malformations and Abnormalities of Growth

To take part in this study you/your child have a vascular malformation, a type of blood vessel disorder whose cause is unknown.

The investigators will do this by looking at changes in the genes and proteins in the cells of the malformation as well as normal cells.

The investigators are doing this research because currently there is no known cause of vascular malformations and no way to know whether or not other health problems will occur in addition to the malformation. Through this research we hope to create standard methods for doctors to examine and treat people with vascular anomalies.

If you/your child agree to participate

  1. Informed consent and permission to use or disclose you/your child's health information for reserve purposes will be obtained by the research team. You will receive a copy of the consent form.
  2. You/your child will be examined by a physician from the research team and interviewed about your medical background and condition every year for five years.
  3. You/your child will have photographs taken of the affected area at each visit.
  4. You/your child will have two, one time biopsies or skin samples taken by a dermatologist. Skin areas will be numbed with lidocaine and a 4 or 5 millimeter (or approximately 0.15 to 0.19 inch) sample will be taken in two different locations. The dermatologist taking the skin sample will use every effort to choose an area that can be covered by clothing or kept out of sight to others. The doctor will either use gelfoam or one stitch/suture per biopsy to seal off the area, which helps with healing and preventing bleeding. If a stitch is placed in the biopsy site, another visit about 7-10 days following the procedure will be necessary to remove the stitch.

5. You may still participate in the study if you consent to having only one biopsy taken of your affected (lesion) skin and not one of your unaffected (normal) skin.

Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Procedure: skin biopsy
Two skin biopsies will be taken one time
Experimental: single group single arm study
Open no masking is used. All involved know the identity of the intervention assignment
Intervention: Procedure: skin biopsy
Not Provided

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

Inclusion Criteria:

  • Greater than 1 year of age
  • Diagnosis of vascular malformation
  • Each patient's authorized legal guardian must understand the nature of the study and must provide written informed consent. Each patient must also give assent to study participation given they have the cognitive capacity to do so.

Exclusion Criteria:

  • Patients less than 1 year of age
  • Vascular malformations likely to result in poor wound healing or located in areas of the body prone to significant scarring
  • Individuals with vascular malformations and previous diagnosis of disseminated intravascular coagulopathy
Sexes Eligible for Study: All
12 Months and older   (Child, Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
CHW 08/204, GC 821
Not Provided
Not Provided
Beth Drolet, Medical College of Wisconsin
Medical College of Wisconsin
Children's Research Institute
Principal Investigator: Kelly Duffy, MD Children's Hospital and Health System Foundation, Wisconsin
Medical College of Wisconsin
January 2014

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