First Case of Accelerated Healing of a Recalcitrant Diabetic Ulcer Using Purified Amniotic Fluid

Abstract

We report the first case of recalcitrant diabetic wound treated successfully by twice-daily applications of a sterile fraction of human purified amniotic fluid (ViX001) obtained from thoroughly screened volunteers at the time of planned c-section at the term of normal pregnancies. Our product ViX001 was generated through a proprietary process and kept in frozen one milliliter (1 ml) vials (protein content was ~1mg/ml) thawed prior to applications (shelf life at 34oF of at least two weeks).

Keywords: Diabetic Foot Ulcer; Diabetic Wound; Exosomes; Extracellular Vesicles; Inflammation; Neoangiogenesis; Pain; Purified Amniotic Fluid; Regenerative Medicine; Tissue Repair; Wound Healing.

Figure 1:

Evolution of the diabetic ulcer of the patient with twice daily applications of a sterile fraction of human purified amniotic fluid (hPAF) ViX001. The left picture shows the wound after 4.5 months of standard treatment (December 15, 2022). The next picture is on the day of the first application of HPAF (January 8, 2023). Picture 7 from the left is the day of the last ViX001 treatment (March 8, 2023), and the next two pictures are after two weeks and 6.5 months of follow-up, respectively. Note the immediate impact of ViX001 on inflammation of surrounding tissues and the progressive filling of the ulcer with new healthy skin tissue.