(CS-019) The Use of an Autologous Multilayered Leukocyte, Platelet and Fibrin Patch in Wagner Grade 2 and 3 Diabetic Foot Ulcers

In a recent study, Wagner Grade 2 diabetic foot ulcers (DFU) proved to be the most prevalent(~42%).  Wagner Grade 3 DFU were next(34%) whereas only 12% were Grade 4.  As noted by Shah et al, “Elevated HbA1c levels, pre-existing peripheral arterial disease, and neuropathy strongly correlate to advanced Wagner's grade and need for amputation.”  While standard of care for DFU is accepted as offloading, debridement, vascular intervention, glucose control and local wound management, Wagner Grade 2 DFU and greater do not always respond to these standards and need advanced therapies.  The use of an autologous multilayered leukocyte, platelet and fibrin patch in this population has proven to be effective in not only promoting granulation but also covering exposed bone, joint or tendon.  This case series presents patients with Wagner Grade 2 or greater DFU that responded exceptionally well to the MLPF patch.

Methods:

Several patients were treated with this innovative product and four demonstrated exceptional results.  Ages ranged from 48-76.  Two ulcers were Wagner grade 2 while the other two were Wagner Grade 3.  Several had recent vascular interventions.

Results:

One patient, a 48-year-old male with a history of chronic kidney disease on hemodialysis and diabetic neuropathy presented with a longstanding wound on the posterior ankle that failed to heal with conservative products. In 3 weeks and 3 applications, the wound went from 1.08 cm² to fully closed.  A 2^nd patient, a 65-year-old male with diabetic neuropathy, COPD, and hyperlipidemia, had a wound for over 8 months with no real improvement noted.  After just 4 applications, the wound went from 0.5 x 0.4 cm to fully closed.  A 3^rd patient, a 76-year-old male presented with a chronic Wagner grade 3 ulcer over the first metatarsal head. Initial area prior to start of therapy was 4.4 cm² .  After 10 weeks of therapy, the wound fully closed.  Finally, the fourth patient, a 71-year-old male, presented with a Wagner grade 2 ulcer on their great toe with an area of 0.7 cm²  that failed to respond to conservative treatment.  Within 7 weeks, this chronic ulcer fully closed.

Discussion:

In this case series, Wagner Grade 2 and 3 diabetic foot ulcers were treated with a novel autologous multilayered leukocyte, platelet, and fibrin patch.  This innovative therapy helped close chronic wounds that failed to heal with other conservative and advanced therapies and ultimately prevented further infections and possible amputations.