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CompletedNCT01105676Updated Jan 7, 2014

Vascular Malformations and Abnormalities of Growth

An interventional study of skin biopsy in Abnormality, sponsored by Medical College of Wisconsin. Completed at 1 site in United States. Open to participants aged 12 Months and older. Per ClinicalTrials.gov, last updated 2014-01-07.

Sponsored by Medical College of Wisconsin · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
12 Months and older
Sex
All
01

Study 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.

Read the 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.
  1. 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.
02

Conditions studied

  • Abnormality

Keywords

  • vascular malformation
  • vascular anomalies
  • abnormalities of growth
  • overgrowth
  • subjects with vascular malformations abnormalities of growth.
03

In context

Vascular Malformations

83 studies on the registry are indexed under Vascular Malformations; 28 are open to participants now.

This study's planned enrollment of 50 is close to the median of 51 across 48 interventional studies indexed under Vascular Malformations.

Browse Vascular Malformations studies →

Lead sponsor

Medical College of Wisconsin is the lead sponsor of 540 studies on the registry; 120 are open to participants now.

Of its 71 completed or terminated interventional studies of FDA-regulated products, 56 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Months and older
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    single group single arm study

    Open no masking is used. All involved know the identity of the intervention assignment

    Procedure: skin biopsy

Interventions

  • Procedureskin biopsy

    Two skin biopsies will be taken one time

06

What researchers measure

Primary outcomes

  1. Percent of growth over time

    Time frame: 5 years

Secondary outcomes

  1. Patient specific gene and protein expression levels that can distinguish affected from unaffected tissue in patients.

    Time frame: 5 years

07

Study locations

1 site
  • Childrens Hospital of Wisconsin
    Milwaukee, Wisconsin 53226, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 7, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01105676
Lead sponsor
Medical College of Wisconsin
Collaborators
Children's National Research Institute
Responsible party
Beth Drolet (Professor and Vice Chairman of Pediatric Dermatology, Medical College of Wisconsin) — Principal investigator
First posted
Apr 16, 2010
Start date
Nov 2008
Primary completion
Dec 2013
Completion
Dec 2013
Last update
Jan 7, 2014

Study contacts

Kelly Duffy, MD
principal investigator · Children's Hospital and Health System Foundation, Wisconsin

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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Discussion

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