Bioelectric Field Imaging Near Human Skin Wounds

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-08-31

Study Completion Date

2007-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Wounds

Keywords

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Hemophilia
* Fever

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Eastern Virginia Medical School

Principal Investigators

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Antoinette F. Hood, M.D.

Role: PRINCIPAL_INVESTIGATOR

Eastern Virginia Medical School

Locations

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Virginia Clinical Research, Inc.

Norfolk, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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R44GM069194-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

BFI and wounds

Identifier Type: -

Identifier Source: org_study_id