WoundsNCT00355823
Bioelectric Field Imaging Near Human Skin Wounds
An observational study of Wounds, run by National Institute of General Medical Sciences (NIGMS) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Wounds
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Apr 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Two age groups will be studied: 1. Young adults 18-19 years old; and 2. older adults 65-80 years old.
Who may be able to join
- Aged 18-30 years or 65-80 years
- Chronic leg ulcer present
- Diabetic
Who cannot join
- Hemophilia
- Fever
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23507
About this study
Official title: Phase I Study of the Electric Field Near Human Skin Wounds
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.
- Conditions
- Wounds
- Keywords
- electric field, wound current, wound healing, bioelectric field, chronic ulcer, diabetic, Diabetes, aging
- Medical subject headings
- Wounds and Injuries, Diabetes Mellitus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2006 (estimated)
- Study startAug 2006
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of General Medical Sciences (NIGMS)
- Sponsor type
- US National Institutes of Health
- Investigators
- Antoinette F. Hood, M.D., Principal investigator, Eastern Virginia Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00355823
- Sponsor's protocol ID
- BFI and wounds
- Other IDs
- R44GM069194-03
- Status last verified
- Nov 2006
- First submitted
- 24 Jul 2006
- Last updated
- 21 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of the Electric Field Near Human Skin Wounds
- ClinicalTrials.gov ID
- NCT00355823
- Acronym / sponsor ID
- BFI and wounds
- Conditions
- Wounds
- Keywords
- electric field, wound current, wound healing, bioelectric field, chronic ulcer, diabetic, Diabetes, aging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Institute of General Medical Sciences (NIGMS)US National Institutes of Health
- Study start
- Aug 2006
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 25 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Two age groups will be studied: 1. Young adults 18-19 years old; and 2. older adults 65-80 years old.
Key inclusion criteria (3 listed)
- Aged 18-30 years or 65-80 years
- Chronic leg ulcer present
- Diabetic
Key exclusion criteria (2 listed)
- Hemophilia
- Fever
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoinette F. Hood, M.D. principal investigator
Eastern Virginia Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wounds, run by National Institute of General Medical Sciences (NIGMS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2008.