Posted by schlunsg on Wednesday, March 2, 2016 in Progress Report.

Progress Report #7

Background: “Diabetes is increasingly prevalent, affecting approximately 29.1 million Americans today. Twenty-five percent of diabetic patients develop diabetic foot ulcers (DFUs) over their lifetime. About 80,000 lower-limb amputations occur in the U.S. every year as a result of DFUs. The current standard of care passively treats the DFU with an off-loading total contact cast. Due to this passive healing method, DFUs may not heal completely thus increasing the risk of infection and possible amputation. In recent years, studies have shown that low-level light therapy (LLLT) is a viable, active treatment method that accelerates wound healing and decreases the incidence of infection. This team developed a medical device, LumaSil, utilizing LLLT with infrared (IR) and blue light to actively heal DFUs as an addition to the standard of care. LumaSil is a low-risk, waterproof, shock resistant device that seeks to actively heal DFUs with no additional effort from the patient. This device automatically controls the therapeutic dosage of light using custom circuitry. Incorporated into the cast, this device is simple to apply, durable, and low-profile. Through a feasibility study, the team worked to prove that LumaSil is safe, automated, and will reduce healing time and incidence of infection.”

As of our last report, we had submitted our IRB proposal to the board and our circuitry was nearing completion.

Since then:

• We have added a new page dedicated to the LumaSil device model, which can be found under the “LumaSil” tab.
• Several project files have been updated including an updated Gantt Chart, all Oral Presentations to date, information concerning our expected FDA device classification, and our current list of electronic references. All of these can be found under the “Project Files” tab.
• The IRB board has gotten back to us with some new corrections for our proposal, which has been updated and resubmitted as of today.
• We performed some rudimentary testing of our fiberoptics to determine how much light is lost depending on the radius of the bend. Based on this preliminary testing, our device loses approximately 5.3% of the illumination generated by any single LED, which is well within our desired output.
• We have made some significant changes to our circuitry, moving away from the timer chips towards a smaller, more compact, and more accurate micro-controller. This change will increase the functionality and form factor of the design, however, will require extra time to redesign and test the circuit. We intend to finish this during Spring Break (March 5 – March 13), so that we have a functional prototype when we return from break.

Based on these achievements and slight changes to the design, we expect to still meet our objectives within the timeline laid down by our Gantt Chart (under Project Files). Our required budget has increased slightly due to the new circuit components, but is still within what we expected. The next two weeks will be dedicated entirely to finishing a functional prototype, which includes building the circuit, programming the micro-controllers, and testing the finished circuit so that we can present it during our next Oral Presentation.