The use of a new tissue allograft, which can be injected into areas of high pressure in the foot, has demonstrated clinical improvement in a number of real-life cases, according to a presentation delivered at the Desert Foot Conference (4–7 December 2019, Phoenix, USA). Described as “an adipose matrix” derived from another part of the human body, speaker Jodi Schoenhaus (Boca Raton, Florida, USA) told those in attendance that “this technology is going to change the wound care world in the next 10 years”.
Developed by non-profit organisation MTF Biologics, the Leneva dermal matrix was developed to “advance the treatment of complex surgical wounds, […] aid in tissue reconstruction” and support wound closure “by providing protective coverage and promoting tissue integration”, according to a press release.
Introducing the matrix, Schoenhaus said: “This product is the first of its kind in this arena, and we are able to use the graft for diabetic foot ulcer prevention, fat pad reconstruction, pressure ulcers, and even deep tunnelling wounds.” It was explained further that Leneva is produced by taking tissue from a donor, before it is processed by MTF Biologics and ultimately injected (or placed around) a patient’s fat pad.
The presenter revealed that there are many possible recommendations for use in patients who have significant fat pad atrophy, high-pressure wounds or high-pressure areas in the foot. Discussing the procedure, Schoenhaus outlined that “what we have at day zero is a matrix, so you are injecting the framework of the tissue which, over the course of seven days, leads to the development of cytoskeletal cells and the infiltration of some of the adipose scaffold”.
After another seven days, it has been found that adipose sites and cell differentiation can be seen, generating new tissue. “It really is a new solution for foot cushioning,” commented the speaker, who added that “you can use it instead of external loading and offloading pads to increase patient compliance and ensure adherence to your recommendations.” Other benefits were also highlighted, with Schoenhaus articulating that Leneva can be used to reduce peak pressure and offload higher pressure areas that are leading to major wounds, pain and other complications in patients.
“Above all, we want to decrease pain and inflammation, support healing of non-infected wounds, allow for an improved cosmesis, and improve quality of life,” Schoenhaus said, before pointing to other patient populations who could benefit from this procedure; these include “rheumatoid arthritic patients where the disease is causing joint deformities and skin breakdown,” and “traumatic atrophy where there is no fat pad and many other situations causing both pain and discomfort”.
Schoenhaus then provided a closer analysis of success with a dermal filler in treating a series of patients, which sparked the concept of internal offloading. Regarding the first, she said: “The patient came to me in December 2016: he was neuropathic, had a callus foot-type, significant atrophy, as well as a non-healing area that had been present for years. The recommendation was multifarious and involved sesamoids, local skin grafts, offloading and debridement, but nothing was working.” With the use of the dermal matrix, the wound closed within one week and, to date, has not recurred.
Another case involved a patient with grade one ulceration who also had peripheral arterial disease and was not a great candidate for revascularisation. “Through the use of a dermal graft, we were able to inject an area, offload post-procedure with a pad just for a couple of weeks, and ultimately heal her ulcer,” said Schoenhaus.
Concluding her presentation, the speaker stated: “The outcome of these cases, and our findings, is that with the use of these injections there is a clinical improvement, a decrease in peak pressure at the site of injection (as well as in the dermal layers), and a decrease of keratin build-up in the callus tissue. I think that you should really start to implement this technique and think about the patients you can apply it to in your own practice, as it is going to be a game-changer.”
Marc Long, vice president of research and development at MTF Biologics, also made a statement: “With the novelty of our adipose technology, along with our unique and patented deep-reticular meshed dermal tissue, we will add to our ever-growing family tree. We are proud to continue to harness the power of allograft tissue, and to branch out to create the world’s most well-rounded and innovative set of biologic solutions for treating even the most complex wounds.”