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CompletedNCT00355823Updated May 21, 2008

Bioelectric Field Imaging Near Human Skin Wounds

An observational study in Wounds, sponsored by National Institute of General Medical Sciences (NIGMS). Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-05-21.

Sponsored by National Institute of General Medical Sciences (NIGMS) · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
40
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Wounds

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Keywords

  • electric field
  • wound current
  • wound healing
  • bioelectric field
  • chronic ulcer
  • diabetic
  • Diabetes
  • aging
03

In context

Wounds and Injuries

5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.

This study's enrollment of 40 is below the median of 135 across 1,597 observational studies indexed under Wounds and Injuries.

Browse Wounds and Injuries studies →

Lead sponsor

National Institute of General Medical Sciences (NIGMS) is the lead sponsor of 19 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Hemophilia
  • Fever
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
40 participants (actual)
06

Study locations

1 site
  • Virginia Clinical Research, Inc.
    Norfolk, Virginia 23507, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00355823
Lead sponsor
National Institute of General Medical Sciences (NIGMS)
First posted
Jul 25, 2006
Start date
Aug 2006
Primary completion
Apr 2007
Completion
Apr 2007
Last update
May 21, 2008

Study contacts

Antoinette F. Hood, M.D.
principal investigator · Eastern Virginia Medical School

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2006. You cannot join it, but the record below documents what was studied.

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