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Validation of Tissue Oxygenation Biomarker to Assess Healing of Diabetic Foot Ulcers using a Low-Cost Hand-Held Optical Imager
Summary Data Summary
Applicant Godavarty, Anuradha
E-Mail Address godavart@fiu.edu
Project Title Validation of Tissue Oxygenation Biomarker to Assess Healing of Diabetic Foot
Ulcers using a Low-Cost Hand-Held Optical Imager
CBU ID 18AU3918
External SubContract ID 32307-35
Diabetic Complication Wound Healing
Funding Program Group Pilot & Feasibility [PF2018]
Abstract Of the nearly 29.1 million people diagnosed with Diabetes Mellitus (DM) in the
USA, up to 25% develop diabetic foot ulcers (DFUs). Diabetic wounds become
chronic for a variety of reasons including a suboptimal inflammatory phase of
wound healing. An obstacle to development of therapies is the availability of
validated biomarkers to assess healing, infection, and/or risk for recurrence.
The clinical standard of assessing healing is from visual assessment of wound
color, degree of epithelization, and size reduction across weeks of treatment.
Oxygenation and blood flow to wound site has been measured using Doppler
ultrasound (DUS), transcutaneous oxygen measurements (TCOM), hyperspectral
imaging (HSI), or near-infrared spectroscopy (NIRS). While all these imaging
tools have been applied in studies of DFUs, most have been limited to TO changes
away from the wound (as blood flow by DUS) or at discrete points around the
wound (as in TCOM and NIRS). Additionally, HSI used visible wavelengths,
limiting its ability to image below the intact skin surface. There has been no
validated TO-based biomarker developed to date to assess healing
(subcutaneously) at the wound site during treatment. Use of NIR wavelengths
allows subcutaneous imaging, unlike visible wavelengths used in HSI for surface
imaging of wounds. At Optical Imaging Laboratory, we have developed a low-cost
hand-held wide-field NIRS system to subcutaneously measure TO of the wound area.
Our pilot studies demonstrated detection of subcutaneous TO changes at the wound
site and longitudinally across weeks of care and healing. Herein, the objective
is to validate and establish a TO-based biomarker for subcutaneous assessment of
healing in DFUs via controlled phantom studies and longitudinal in-vivo studies
across weeks of treatment. Our specific aims include: (i) Validate and calibrate
the low-cost near-infrared optical scanner to measure TO changes, via controlled
phantom studies;(ii) Develop a quantifiable TO biomarker for assessing healing
of 10 DFUs via longitudinal studies across 4-weeks of treatment. The proposed
work is innovative in obtaining subcutaneous TO maps using a low-cost, hand-held
near-infrared optical scanner (NIROS) using only a few discrete wavelengths
(unlike HSI), and also perform real-time non-contact imaging. The proposed study
can eventually impact DFU wound care by allowing clinicians to personalize
treatment plan so as to minimize TO reduction-mediated failure of healing.
Application PDF Application Research Plan
Status Contract Executed
Key Personnel Wensong Wu
Robert Kirsner
Salary Total Costs 46312
Supply Total Costs 2892
Equipment Total Costs 0
Travel/Other Total Costs 22094
Direct Costs 71298
Indirect Costs Proposed 28702
Total Costs Proposed 100000
Total Costs Approved 100000
Start Date 11/1/2018
End Date 10/31/2019
IFO Name Gutierrez, Robert
IFO E-Mail Address gutierrr@fiu.edu
IACUC/IRB No. 13-0092
IACUC/IRB Institution Florida International University
Entity ID No. 65-0177616
Report Request Date 11/1/2021
T1D NO
TypeCount
Invoices 19
Progress Reports 2
Data Submission


Invoices
UrlCBU IDExternal IDInstitutionDateDirectIndirectInvoiceBalancePDF
  View  18AU391832307-35Florida International University9/29/2020$1,139.35$529.80$1,669.15$73.14View PDF
  View  18AU391832307-35Florida International University8/18/2020$3,433.55$1,596.61$5,030.16$73.14View PDF
  View  18AU391832307-35Florida International University8/16/2019$3,094.67$1,439.02$4,533.69$73.14View PDF
  View  18AU391832307-35Florida International University7/5/2019$2,065.41$960.42$3,025.83$73.14View PDF
  View  18AU391832307-35Florida International University7/23/2019$8,198.97$3,812.52$12,011.49$73.14View PDF
  View  18AU391832307-35Florida International University7/20/2020$2,778.83$1,292.17$4,071.00$73.14View PDF
  View  18AU391832307-35Florida International University6/19/2020$4,589.40$1,074.02$5,663.42$73.14View PDF
  View  18AU391832307-35Florida International University5/13/2020$2,309.70$1,074.02$3,383.72$73.14View PDF
  View  18AU391832307-35Florida International University4/14/2020$2,309.70$1,074.02$3,383.72$73.14View PDF
  View  18AU391832307-35Florida International University3/19/2020$6,602.73$3,070.27$9,673.00$73.14View PDF
  View  18AU391832307-35Florida International University2/18/2020$9,862.20$2,995.85$12,858.05$73.14View PDF
  View  18AU391832307-35Florida International University2/1/2021$2,477.73$1,152.15$3,629.88$73.14View PDF
  View  18AU391832307-35Florida International University12/16/2019$2,309.70$1,074.02$3,383.72$73.14View PDF
  View  18AU391832307-35Florida International University11/20/2020$1,438.32$668.82$2,107.14$73.14View PDF
  View  18AU391832307-35Florida International University11/20/2019$12,705.76$4,318.09$17,023.85$73.14View PDF
  View  18AU391832307-35Florida International University10/21/2020$2,013.66$936.35$2,950.01$73.14View PDF
  View  18AU391832307-35Florida International University1/7/2022$26.06$12.12$38.18$73.14View PDF
  View  18AU391832307-35Florida International University1/4/2021$1,438.31$668.82$2,107.13$73.14View PDF
  View  18AU391832307-35Florida International University1/16/2020$2,309.70$1,074.02$3,383.72$73.14View PDF
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