Non-Invasive Assessment of Wound Healing With Optical Methods
Completed
Conditions studied: Diabetic Foot Ulcers
In brief
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.
Key facts
- Study ID
- NCT00578604
- Run by
- Drexel University College of Medicine
- People needed
- 38
- Starts
- 2007-09-01
- Expected to finish
- 2014-06-01
- Last updated by the study team
- 2017-03-30
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may not qualify if…
- 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
Where it is running
- Drexel University College of Medicine Wound Care Center — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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