Microcautery for the Treatment of Spider Leg Veins

September 10, 2019 updated by: Doaa M. Selim, Assiut University

Microcautery Evaluation for Treatment of Leg Spiders

To Evaluate the role of micro-cauterization use in the treatment and disappearance of spider leg veins.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Spider veins on the lower limbs are very common and have been reported to be presented in 41% of women over 50 years old. Sclerotherapy as a traditional treatment for spider veins has a low cost, though it may have adverse sequelae. Lasers have shown fewer but still substantial complications as well.1 Spider veins are small superficial veins that widen and become visible, often on the legs and most cutaneous spider veins are abnormalities of the horizontal vascular skin plexus or capillary loops.2 Spider leg veins are composed of a feeder vessel and ectatic venous sprouts in the reticular dermis. Their depth is between 180 µm and 1 mm in the skin.3 Spider veins may have a diameter that reaches several millimetres and can be blue, purple or red and may appear in the form of thin lines, webs or branches.4 There is a scarce available data from literature about the role of micro-cauterization in the treatment of spider veins. The micro-cauterization is an alternative in management of spider veins that delivered via Mole Freckle Pen German Technology.4 Cautery is a safe and effective tool for the treatment of superficial and small skin lesions. It is simple, cheap, and requires minimal training and the results are usually satisfactory Technology Specifications with insulated micro steel needle use current: 5V / 1A of 5-speed free adjustment.5 The current study aims to evaluate the role for micro-cauterization in the treatment and disappearance of spider leg veins.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • were patients with spider veins of less than 2.0 mm in diameter.

Exclusion Criteria:

  • were patients with diabetes, anticoagulation therapy and/or patients with a known history of keloids

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Female with leg spider veins
Females at the age of 20 to 45 not known diabetics or hypertensive complaining of leg spider veins.
Device: Mole Freckle Pen
Insulated micro steel needle use current: 5V / 1A of 5-speed free adjustment.5

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short term results after 3 weeks.
Time Frame: 3 weeks
Compare between the shape of spider leg veins pre and post the cauterization session depending on standard Oriented photos taken pre and post.
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long term results after 3 months.
Time Frame: 3 months
Study, monitor and evaluate the long term results of the cautery session after 3 months and if there is any reappearance of the spider veins with a standard Oriented photos taken.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Doaa M. Selim, Resident, Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2019

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

October 1, 2020

Study Registration Dates

First Submitted

August 25, 2019

First Submitted That Met QC Criteria

August 26, 2019

First Posted (Actual)

August 28, 2019

Study Record Updates

Last Update Posted (Actual)

September 11, 2019

Last Update Submitted That Met QC Criteria

September 10, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • Micro-cautery for leg veins

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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