Non-Invasive Assessment of Wound Healing With Optical Methods
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal, Podiatry, Diabetes |
| Therapuetic Areas: | Endocrinology, Gastroenterology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/2/2016 |
| Start Date: | September 2007 |
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.
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.
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
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