3D Nanofabricated Polymer Scaffold Used to Treat Diabetic Foot Ulcers: A Case Series of Four Patients

Abstract Body: Aims The advancement of wound healing technology, and, specifically the study of the skin microbiome, have led to the development of a new 3D nanofabricated synthetic polymer (3DNSP*) product composed of naturally inherent structures known to encourage homeostasis and the body’s natural wound healing process. 3DNPS* provides a critical prerequisite for successful tissue regeneration, a structure designed to mimic the scaffolding of the extracellular matrix. A case series of four patients with 5 wounds is presented here, showing the efficacy of 3DNPS in treating difficult diabetic foot wounds. Materials & Methods Four patients with five wounds who failed previous standard of care methods were treated with 3DNPS.  All were diabetic patients with neuropathic wounds.  Average age was 56 (range 51-68).  Average wound size was 3.83cm (range 1.08cm-6.75cm).   All wounds were treated with 3DNSP with weekly dressing changes, compression and off loading.  3DNSP is a USFDA regulated 361 Human Cellular Tissue (HCT/Ps) product under 21 CFR part 1271 part 361.  It is a synthetic scaffold containing no human or animal tissue/cells, and is designed to harness the innate inflammatory response, promote progression to the proliferative phase, and enable the regeneration of functional, native skin. 3DNSP is a 3D nanofabricated electrospun polymer that is available at room temperature.    It is applied directly to a clean, debrided wound and secured with a compressive dressing and offloading as needed.   Results All four diabetic patients who failed previous standard of care were treated with PWM.  Infections were treated with antibiotics and all infected bone and soft tissue was  surgically removed prior to treatment.  Affected limbs were offloaded. All wounds healed with an average number of 5 applications (range 3-9), in an average of 7.4 weeks (5-11).  Average wound size was 3.83cm (range 1.08cm-6.75cm).  Average wound area reduction was 76% in 3 weeks.  No wound  recurrence, nor adverse events or complications were reported.   Conclusion Clinical outcomes in this series show safety and efficacy of a novel 3D nanofabricated electrospun polymer scaffold designed to mimic the ECM, with no reported wound or product related complications in treatment of DFU patients failing multiple previous treatment methods.