Posted by schlunsg on Monday, April 4, 2016 in Progress Report.

Progress Report #9

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 March 23, 2016 our IRB proposal has been successfully reviewed and accepted. This means that we have permission to begin our feasibility study in the medical center at our earliest convenience.

Since our last report,

• We have nearly completed the code that our microcontrollers will be running. There are some minor bugs that should be resolved within the week, and then the code must only be uploaded to each controller.
• The PCBs (printed circuit boards) were ordered a little over a week ago from China, and we expect them to arrive sometime later this week, or at latest the beginning of next week. Once they arrive, we will begin the final assembly of our LumaSil devices.
• Early assembly of our devices has begun, which includes the silicone halo, the connector which interfaces between the halo and PCB, and the battery holders. All of these pieces are being actively added to our weather-proof boxes and will be completely ready for when the PCBs arrive.

The primary delay that was introduced this week was our PCBs not arriving as early as we were hoping. This pushes back the feasibility testing of our device to sometime next week, however, we intend to begin the control portion of our feasibility study this coming Wednesday with the normal standard of care patients. The remainder of this week will be seen finishing 10 boxes plus silicone halos for the 10 patients who will be receiving LumaSil. Barring any more major delays, we should then be able to begin the actual feasibility study with our device next Wednesday, April 13.

This is our last official progress report, so we hope you have enjoyed following our project thus far. We have one last major website update planned, but besides that, see you on Design Day!

The LumaSil Team:

Siegfried Schlunk, Brandon Fross, John Mendoza, Laurel Piper, Liza Stedman, Ahbid Zein-Sabatto