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Bioelectric Field Imaging Near Human Skin Wounds
This study has been completed.
Study NCT00355823   Information provided by National Institute of General Medical Sciences (NIGMS)
First Received: July 24, 2006   Last Updated: May 20, 2008   History of Changes

July 24, 2006
May 20, 2008
August 2006
April 2007   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00355823 on ClinicalTrials.gov Archive Site
 
 
 
Bioelectric Field Imaging Near Human Skin Wounds
Phase I Study of the Electric Field Near Human Skin Wounds

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.

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.

Phase I
Observational
Case-Only, Prospective
Wounds
 
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
40
April 2007
April 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Hemophilia
  • Fever
Both
18 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00355823
Antoinette F. Hood, Eastern Virginia Medical School
BFI and wounds, R44 GM069194-03
National Institute of General Medical Sciences (NIGMS)
 
Principal Investigator: Antoinette F. Hood, M.D. Eastern Virginia Medical School
National Institute of General Medical Sciences (NIGMS)
November 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP