TheraIndx Lifesciences Pvt Ltd, Sy. No.27, Deganahalli, Budihal Post, Nelamangala, Bangalore, India 562123
Diabetic foot ulcers or injuries are responsible for more hospitalizations than any other complication of diabetes. Bacterial infection is recognized as an important factor associated with impaired healing in diabetic wounds. A non-conventional medicated bandage was tested in in-vitro and in-vivo assays for potency, safety and toxicity and for anti-bacterial and anti-diabetic activities in animal models.
The in vitro assays were modified and adopted from conventional microbial inhibition and antibiotic susceptibility testing. Zone of inhibition assay on solid agar and rate of kill, half-life and minimum inhibitory concentrations were determined in broth culture. A panel of bacteria were tested for in-vitro biofilm inhibition activity.
In vitro toxicity assays were performed with Balb/c 3T3 cells line and biocompatibility studies such as skin sensitization, intra-cutaneous reactivity and acute systemic toxicity were conducted in mice, rats and rabbits.
Efficacy studies were performed in excision and chemically induced diabetic wound models in rats which are validated models for discovery of anti-diabetic drug candidates and the novel bandage has shown promising results compared to some of the marketed products. These models meet the FDA recommended criteria for validation of medical devices.