Diabetic Foot UlcersNCT00578604
Non-Invasive Assessment of Wound Healing With Optical Methods
An observational study of Diabetic Foot Ulcers, run by Drexel University College of Medicine at 1 site in United States.
Trial summary
The objective of this project is to further the development of a non-invasive optically based NIR (Near Infrared) device to enable the quantitative diagnosis, monitoring and treatment optimization of chronic wounds (especially diabetic) in a clinical setting. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Foot Ulcers
- What is being tested?
- diffuse near infrared spectroscopy measurements
- Type of treatment
- Medical device
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Jun 2014
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Recruited patients will be patients with diabetes who have chronic wounds and will likely have other co-morbidities associated with chronic diabetes. Control subjects do not have diabetes and do not have wounds.
Who may be able to join
None listed.
Who cannot join
- Subject must not be <18 or >65 years of age
- Subjects with major infections, abscesses, or untreated osteomyelitis will be excluded until appropriately treated.
- Subjects will not be excluded based upon the existence of other co-morbidities associated with chronic diabetes, including retinopathy, nephropathy, peripheral neuropathy, or cardiovascular disease except as follows:
- Subjects who have moderate to severe vascular insufficiency (defined as ankle brachial index <0.75 or toe-brachial index <0.5)
- Subjects who are unable to return for weekly follow-up appointments will not be included.
- Pregnant or lactating people will not be invited to participate.
- Subjects who are allergic to Tegaderm
Trial locations and contacts
1 site in 1 country.
United States1 site
Drexel University College of Medicine Wound Care Center
Philadelphia, Pennsylvania, 19102
About this study
The objective of this project is to further the development of a non-invasive optically based NIR (Near Infrared) device to enable the quantitative diagnosis, monitoring and treatment optimization of chronic wounds (especially diabetic) in a clinical setting. The end goal of this project is a portable and compact device that would be simple to operate by minimally trained health care personnel. Our animal studies have shown that the early healing of chronic wounds can be characterized by absorption and scattering of light at near infrared wavelengths ranging from 680 nm to 950 nm. If our project is successful we will be providing the clinician the ability to predict if a wound is healing and if a particular treatment is successful in accelerating healing before any changes are observed by wound size contraction or other visible clinical signs. Our hope is that the fNIR optical device will provide conclusive therapeutic treatment information as early as 5 weeks after initial evaluation, before it would be obvious on gross examination of the patient.
- Conditions
- Diabetic Foot Ulcers
- Being tested
- diffuse near infrared spectroscopy measurements
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diffuse near infrared spectroscopy measurementsDevice
Measure blood flow to diabetic wounds
| Study group | Role | What they receive |
|---|---|---|
| Patients with a diabetic wound | Patients with a diabetic wound Receives: Device: diffuse near infrared spectroscopy measurements | |
| Control | Patients without a diabetic wound Receives: Device: diffuse near infrared spectroscopy measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
diffuse near infrared spectroscopy measurements
The end goal of this project is a portable and compact device that would be simple to operate by minimally trained health care personnel and is comparable to SOC doppler.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2007 (estimated)
- Study startSep 2007
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcersStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael S Weingarten, M.D., Principal investigator, Drexel University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00578604
- Sponsor's protocol ID
- 17035
- Status last verified
- Mar 2017
- First submitted
- 20 Dec 2007
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Assessment of Wound Healing With Optical Methods
- ClinicalTrials.gov ID
- NCT00578604
- Acronym / sponsor ID
- 17035
- Conditions
- Diabetic Foot Ulcers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Drexel University College of MedicineUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 21 Dec 2007 (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 objective of this project is to further the development of a non-invasive optically based NIR (Near Infrared) device to enable the quantitative diagnosis, monitoring and treatment optimization of chronic wounds (especially diabetic) in a clinical setting. The end goal of this project is a portable and compact device that would be simple to operate by minimally trained health care personnel. Our animal studies have shown that the early healing of chronic wounds can be characterized by absorption and scattering of light at near infrared wavelengths ranging from 680 nm to 950 nm. If our project is successful we will be providing the clinician the ability to predict if a wound is healing and if a particular treatment is successful in accelerating healing before any changes are observed by wound size contraction or other visible clinical signs. Our hope is that the fNIR optical device will provide conclusive therapeutic treatment information as early as 5 weeks after initial evaluation, before it would be obvious on gross examination of the patient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with a diabetic wound | – | Device: diffuse near infrared spectroscopy measurementsPatients with a diabetic wound |
| Control | – | Device: diffuse near infrared spectroscopy measurementsPatients without a diabetic wound |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Recruited patients will be patients with diabetes who have chronic wounds and will likely have other co-morbidities associated with chronic diabetes. Control subjects do not have diabetes and do not have wounds.
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- Subject must not be <18 or >65 years of age
- Subjects with major infections, abscesses, or untreated osteomyelitis will be excluded until appropriately treated.
- Subjects will not be excluded based upon the existence of other co-morbidities associated with chronic diabetes, including retinopathy, nephropathy, peripheral neuropathy, or cardiovascular disease except as follows:
- Subjects who have moderate to severe vascular insufficiency (defined as ankle brachial index <0.75 or toe-brachial index <0.5)
- Subjects who are unable to return for weekly follow-up appointments will not be included.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diffuse near infrared spectroscopy measurementsMeasure blood flow to diabetic wounds | Device | Control, Patients with a diabetic wound |
Primary outcome
diffuse near infrared spectroscopy measurements
Time frame: 3 years
The end goal of this project is a portable and compact device that would be simple to operate by minimally trained health care personnel and is comparable to SOC doppler.
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 30 Mar 2017.
Related trials for Diabetic Foot Ulcers
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Wearable Insoles for Recurrent Diabetic Ulcer Prevention
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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Better Care Closer to Home: Enhancing Primary and Community Care
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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.
Michael S Weingarten, M.D. principal investigator
Drexel University College of Medicine
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 Diabetic Foot Ulcers, run by Drexel University College of Medicine 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 0 inclusion and 7 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 30 Mar 2017. 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.
What does the primary outcome measure?
diffuse near infrared spectroscopy measurements (time frame: 3 years). It is what the study was designed to measure, not a finding.
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 30 Mar 2017.