Clinical trial NCT00578604: Non-Invasive Assessment of Wound Healing With Optical Methods
Official title: Non-Invasive Assessment of Wound Healing With Optical Methods
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Foot Ulcers
Lead sponsor: Drexel University
Sponsor class: OTHER
First posted: 2007-12-21
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: diffuse near infrared spectroscopy measurements
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Drexel University College of Medicine Wound Care Center
state: Pennsylvania
Study officials:
affiliation: Drexel University College of Medicine
name: Michael S Weingarten, M.D.
role: PRINCIPAL_INVESTIGATOR
References: