The purpose of this study is to test the efficacy of a test item in a wound healing model using db/db mice or Zucker rats.
The db/db mouse and the diabetic Zucker rat are common animal models of delayed wound healing and it can be used if intended clinical use of the test item is in diabetic patients.
Within 6 weeks of age, db/db mice (BKS.Cg-Dock7m+/+LeprdbJ) develope significant obesity, fasting hyperglycemia and hyperinsulinemia (typ II diabetes) with delayed wound healing. The Zucker rat develops typ II diabetes, spontaneously, at an age of 12 to 14 weeks.
The blood glucose level of the animals is determined before wound setting to check the diabetes status .
A dermo-epidermic full-thickness wound, is set para-vertebral with a skin biopsy punch. On each animal two wounds are set under anesthesia and analgesia (on the left and right side of the back), one side for treatment with test item and the other side serves as control. Depending on the test item, wound dressing can be used to cover the wounds.
Wounds are evaluated, scored and photographed on the day of wound setting and thereafter regularly for a defined period. A histopathological evaluation with special focus on the healing process and skin characteristics is performed.