Bioelectric Field Imaging Near Human Skin Wounds

Sponsor

National Institute of General Medical Sciences (NIGMS) (NIH)

Overall Status

Completed

CT.gov ID

NCT00355823

Collaborator

(none)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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.

Study Design

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 :

Aug 1, 2006

Actual Primary Completion Date :

Apr 1, 2007

Actual Study Completion Date :

Apr 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

Hemophilia
Fever

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Virginia Clinical Research, Inc.	Norfolk	Virginia	United States	23507

Sponsors and Collaborators

National Institute of General Medical Sciences (NIGMS)

Investigators

Principal Investigator: Antoinette F. Hood, M.D., Eastern Virginia Medical School

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00355823

Other Study ID Numbers:

BFI and wounds
R44GM069194-03

First Posted:

Jul 25, 2006

Last Update Posted:

May 21, 2008

Last Verified:

Nov 1, 2006

Keywords provided by , ,

Additional relevant MeSH terms:

Wounds and Injuries

Study Results

No Results Posted as of May 21, 2008