NCT00355823

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2006

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 25, 2006

Completed
7 days until next milestone

Study Start

First participant enrolled

August 1, 2006

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

May 21, 2008

Status Verified

November 1, 2006

Enrollment Period

8 months

First QC Date

July 24, 2006

Last Update Submit

May 20, 2008

Conditions

Keywords

electric fieldwound currentwound healingbioelectric fieldchronic ulcerdiabeticDiabetesaging

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Two age groups will be studied: 1. Young adults 18-19 years old; and 2. older adults 65-80 years old.

You may qualify if:

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

You may not qualify if:

  • Hemophilia
  • Fever

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Clinical Research, Inc.

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Wounds and InjuriesDiabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Antoinette F. Hood, M.D.

    Eastern Virginia Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

July 24, 2006

First Posted

July 25, 2006

Study Start

August 1, 2006

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

May 21, 2008

Record last verified: 2006-11

Locations