Bioelectric Field Imaging Near Human Skin Wounds

Wounds Clinical Trial

Official title:

Phase I Study of the Electric Field Near Human Skin Wounds

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00355823
• Other study ID #: BFI and wounds
• Secondary ID: R44GM069194-03
• Status: Completed
• Phase: Phase 1
• First received: July 24, 2006
• Last updated: May 20, 2008
• Start date: August 2006
• Est. completion date: April 2007

Study information

• Verified date: November 2006
• Source: National Institute of General Medical Sciences (NIGMS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Aged 18-30 years or 65-80 years

• Chronic leg ulcer present

• Diabetic

Exclusion Criteria:

• Hemophilia

• Fever

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Wounds

Locations

Country	Name	City	State
United States	Virginia Clinical Research, Inc.	Norfolk	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States,