NCT01735734

Brief Summary

The purpose of this observational study is to ascertain the effects of cutaneous air cooling on vessel diameter within Capillary Malformations (CM).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 28, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

November 28, 2012

Status Verified

November 1, 2012

Enrollment Period

9 months

First QC Date

November 24, 2012

Last Update Submit

November 25, 2012

Conditions

Capillary MalformationLaserSkin Cooling

Keywords

Skin diseaseCapillary MalformationLaser therapy

Outcome Measures

Primary Outcomes (1)

  • To study the effects of cutaneous air cooling on blood vessel diameter in capillary malformation

    In a temperature controlled room, the participant's capillary diameter/depth and skin/core temperatures will be taken from their CM prior to cooling the skin. The patients' CM will be cooled for a duration of 1 minute. The above measurements will be repeated immediately after 1 minute of cooling.

    10 minutes

Study Arms (1)

Capillary malformation

Device: Air cooling to CM site

Interventions

Air cooling to CM siteDEVICE
Capillary malformation

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Capillary Malformation identified through our department database

You may qualify if:

  • Adult more than 16 years of age
  • Patient diagnosed with Capillary Malformation

You may not qualify if:

  • Patients less than 16 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Canniesburn Plastic Surgery Unit, Glasgow Royal Infirmary

Glasgow, G4 0SF, United Kingdom

Location

MeSH Terms

Conditions

Capillary Malformations, Congenital, 1Skin Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Study Officials

  • Irving Ling, MBBS

    NHS Greater Glasgow and Clyde

    PRINCIPAL INVESTIGATOR

  • Adam Gilmour, MBChB, MRCS (Ed)

    NHS Greater Glasgow and Clyde

    STUDY CHAIR

  • Iain Mackay, MBChb, MRCS, FRCS (plast)

    NHS Greater Glasgow and Clyde

    STUDY DIRECTOR

Central Study Contacts

Irving Ling, MBBS

CONTACT

irvingling@nhs.net

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Academic Foundation Doctor, Honorary Clinical Fellow

Study Record Dates

First Submitted

November 24, 2012

First Posted

November 28, 2012

Study Start

February 1, 2013

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

November 28, 2012

Record last verified: 2012-11

Locations

GB(1)