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Bioelectric Field Imaging Near Human Skin Wounds
This study has been completed.

First Received on July 24, 2006.   Last Updated on May 20, 2008   History of Changes
Sponsor: National Institute of General Medical Sciences (NIGMS)
Information provided by: National Institute of General Medical Sciences (NIGMS)
ClinicalTrials.gov Identifier: NCT00355823
  Purpose

The investigators have developed a new non-invasive medical device called the Bioelectric Field Imager. They plan to use this device to measure the electric field near small lancet wounds in 60 volunteers. Their hypothesis is that the electric field is an early stimulus for wound healing and the magnitude of this field will vary with wound healing capability. The investigators will compare the electric fields near arm and leg wounds in males and females in the age groups of 18-30 and 65-80. In addition they will measure these wound fields in diabetics and near chronic ulcers.


Condition Phase
Wounds
Phase I

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Phase I Study of the Electric Field Near Human Skin Wounds

Further study details as provided by National Institute of General Medical Sciences (NIGMS):

Enrollment: 40
Study Start Date: August 2006
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Detailed Description:

We will first characterize the lateral electric field near reproducible skin wounds in healthy male and female subjects 18-30 years of age. A standard superficial, dermal wound 0.5 mm long will be inflicted using the Ascensia Microlet Vaculance by Bayer Health Care with a 21 gauge lancet on its deepest setting. This setting will penetrate the epidermis and stop within the dermis. We will first determine variability within the same individual by measuring the electric field near two wounds close to each other on the volar forearm. We will then determine the variability between different body regions by comparing the wound field near a lancet wound in the volar forearm and one in the leg. If hair is present it will be removed by shaving the wound site prior to wounding. By collecting these data from 10 males and 10 females in both age groups we can determine if there is a gender or age dependence to the field strength. Finally we will determine the lateral electric field near lancet wounds in diabetics and near chronic skin wounds. If these fields are smaller than fields found near acute wounds, it would provide a rationale for future studies imposing electric fields to enhance wound healing.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Two age groups will be studied: 1. Young adults 18-19 years old; and 2. older adults 65-80 years old.

Criteria

Inclusion Criteria:

  • Aged 18-30 years or 65-80 years
  • Chronic leg ulcer present
  • Diabetic

Exclusion Criteria:

  • Hemophilia
  • Fever
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00355823

Locations
United States, Virginia
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Investigators
Principal Investigator: Antoinette F. Hood, M.D. Eastern Virginia Medical School
  More Information

No publications provided

Responsible Party: Antoinette F. Hood, Eastern Virginia Medical School
ClinicalTrials.gov Identifier: NCT00355823     History of Changes
Other Study ID Numbers: BFI and wounds, R44 GM069194-03
Study First Received: July 24, 2006
Last Updated: May 20, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute of General Medical Sciences (NIGMS):
electric field
wound current
wound healing
bioelectric field
chronic ulcer
diabetic
Diabetes
aging

ClinicalTrials.gov processed this record on February 12, 2012