Posted by schlunsg on Monday, February 15, 2016 in Progress Report.

Progress Report #6

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 today, our submission of the IRB is imminent, and our group is confident it will be submitted by the end of this week. By this timeframe, we anticipate receiving word from the IRB board by the week of February 29, right before Spring Break. If a resubmission is required with corrections, we would then expect the second response during the week of March 14, right after Spring Break.

The circuit design is nearly complete, and the current effort is being towards optimizing the size of the PCB (printed circuit board). During the rest of this week we also intend to begin testing various components to make sure they meet our specifications. Among these are:

• timer chips – to ensure that the timing and frequency of LED activity are within previously determined values
• fiber optic bend radius – to determine how much light is lost at varying levels of bending
• fiber optic transference – to determine how much light is output at the end of the fiber optic cables and ensure it is at the level predicted to increase healing rate

Once the PCB design has been finalized, we will be able to order the specific box that will hold the circuit and batteries. Once the box has arrived, we will then be able to finalize a waterproof design to connect the fiberoptic patch to the electric box.

The next two weeks will be almost entirely focused on finishing and testing a functional prototype, so that the feasability study can begin as soon as approval is given. Based on our current progress, we continue to expect we will meet our objectives within our current schedule as well as budget.