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Bioelectric Field Imaging Near Human Skin Wounds

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ClinicalTrials.gov Identifier: NCT00355823
Recruitment Status : Completed
First Posted : July 25, 2006
Last Update Posted : May 21, 2008
Sponsor:
Information provided by:
National Institute of General Medical Sciences (NIGMS)

Brief Summary:
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 or disease
Wounds

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.

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Phase I Study of the Electric Field Near Human Skin Wounds
Study Start Date : August 2006
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): NCT00355823


Locations
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United States, Virginia
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
National Institute of General Medical Sciences (NIGMS)
Investigators
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Principal Investigator: Antoinette F. Hood, M.D. Eastern Virginia Medical School
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Responsible Party: Antoinette F. Hood, Eastern Virginia Medical School
ClinicalTrials.gov Identifier: NCT00355823    
Other Study ID Numbers: BFI and wounds
R44GM069194-03 ( U.S. NIH Grant/Contract )
First Posted: July 25, 2006    Key Record Dates
Last Update Posted: May 21, 2008
Last Verified: November 2006
Keywords provided by National Institute of General Medical Sciences (NIGMS):
electric field
wound current
wound healing
bioelectric field
chronic ulcer
diabetic
Diabetes
aging
Additional relevant MeSH terms:
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Wounds and Injuries