Transcript: Long-term Follow-up in Restoring Soft Tissue Deficits with A Novel Human Adipose Allograft Matrix*

Hello, my name's Dr. Matthew Regulski. I'm the medical director of the Wound Care Institute of Ocean County, New Jersey, and partner in Ocean County Foot & Ankle Surgical Associates.

In the treatment of diabetic foot ulcerations, these patients will have significant recurrences of ulcerations that can lead to higher levels of morbidity and mortality, rehospitalization, and surgery.

In this poster that I am presenting, we utilize Leneva in the prevention of recurrence of diabetic foot ulceration. Given that diabetic foot ulceration carries a 47% mortality rate and the recurrence rate for a diabetic foot ulcer is anywhere from 50% to 70%, we needed something with more longer, sustainable prevention than what is presently available and what we can do.

Remember in the diabetic population that a callous raises their risk for ulceration 11 times greater. When we see these patients that have these risk factors and have a new callous or blood in the callous or they've had a wound that you have closed, Leneva is an excellent choice for long-term control. Leneva is an allograft, adipose-derived matrix which is acellular, and it is shelf stable for up to 15 months. You inject it into the subcutaneous space in order to recruit the patient's own adipocytes to the scaffolding protein. Once that occurs, then the patient's own adipocytes will start secreting new adipose tissue in order to regenerate the scarred plantar fat pad.

Now, we're not saying that we just injected everybody and everybody did great. We still have to see these patients often, and we get everybody in some kind of offloading device, particularly a custom open diabetic shoe.

In these pictures that I am presenting, these were people that had significant diabetic foot ulcerations. Some even required surgical treatment for that to get these areas closed. But for the longterm control, we utilized Leneva because these people still started to have signs of impending breakdown with callous. Some were painful callous, some had blood in the callus, which then leads to the ulceration.

In this series of patients that we did, we have patients that are out to three years without recurrence of their ulceration, a very remarkable feat achieved by this excellent chemistry and the capabilities to reproduce the plantar fat pad.