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. 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

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Abnormality Procedure: skin biopsy Not Applicable

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Vascular Malformations and Abnormalities of Growth
Study Start Date : November 2008
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Arm Intervention/treatment
Experimental: single group single arm study
Open no masking is used. All involved know the identity of the intervention assignment
Procedure: skin biopsy
Two skin biopsies will be taken one time

Primary Outcome Measures :
  1. Percent of growth over time [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Patient specific gene and protein expression levels that can distinguish affected from unaffected tissue in patients. [ Time Frame: 5 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   12 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01105676

United States, Wisconsin
Childrens Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
Children's Research Institute
Principal Investigator: Kelly Duffy, MD Children's Hospital and Health System Foundation, Wisconsin

Responsible Party: Beth Drolet, Professor and Vice Chairman of Pediatric Dermatology, Medical College of Wisconsin Identifier: NCT01105676     History of Changes
Other Study ID Numbers: CHW 08/204, GC 821
First Posted: April 16, 2010    Key Record Dates
Last Update Posted: January 7, 2014
Last Verified: January 2014

Keywords provided by Beth Drolet, Medical College of Wisconsin:
vascular malformation
vascular anomalies
abnormalities of growth
subjects with vascular malformations abnormalities of growth.

Additional relevant MeSH terms:
Congenital Abnormalities
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases