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Non-Invasive Assessment of Wound Healing With Optical Methods

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ClinicalTrials.gov Identifier: NCT00578604
Recruitment Status : Completed
First Posted : December 21, 2007
Last Update Posted : March 30, 2017
Sponsor:
Information provided by (Responsible Party):
Drexel University ( Drexel University College of Medicine )

December 20, 2007
December 21, 2007
March 30, 2017
September 2007
June 2014   (Final data collection date for primary outcome measure)
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.
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Complete list of historical versions of study NCT00578604 on ClinicalTrials.gov Archive Site
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Non-Invasive Assessment of Wound Healing With Optical Methods
Non-Invasive Assessment of Wound Healing With Optical Methods
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.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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.

Diabetic Foot Ulcers
Device: diffuse near infrared spectroscopy measurements
Measure blood flow to diabetic wounds
  • Patients with a diabetic wound
    Patients with a diabetic wound
    Intervention: Device: diffuse near infrared spectroscopy measurements
  • Control
    Patients without a diabetic wound
    Intervention: Device: diffuse near infrared spectroscopy measurements
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
100
June 2014
June 2014   (Final data collection date for primary outcome measure)

Healthy Subject inclusion criteria

  • Subjects must be 18-65 years of age
  • Subjects must have no history of diabetes
  • Subjects must have no history of vascular disease
  • Subjects must have no findings of vascular disease on physical examination
  • Subjects who are not allergic to Tegaderm

Patient Subject inclusion criteria:

  • Subjects must be 18-65 years of age
  • Subjects must have documented diabetes mellitus for at least 6 months.
  • Subjects must have at least one documented chronic wound for a minimum 8 weeks.
  • A chronic wound is defined as any wound that has not healed after 8 weeks and has a minimum surface area of 1cm2. There is no maximum wound size.
  • Wound(s) must be secondary to the complications of diabetes, including vascular disease neuropathy, or both.
  • Wounds must be on the ankles or feet
  • Subjects who are not allergic to Tegaderm

EXCLUSION CRITERIA

  • 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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00578604
17035
No
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Drexel University ( Drexel University College of Medicine )
Drexel University College of Medicine
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Principal Investigator: Michael S Weingarten, M.D. Drexel University College of Medicine
Drexel University
March 2017