1. Any injury of the ankle that required surgery. |
2. Pre-existing ankle trauma. |
3. History of allergy to one or more ingredients of Phlogenzym. |
4. Use of immune suppressing drugs. |
5. Parallel intake of non-steroidal anti-inflammatory drugs or analgesics except paracetamol only during the first two days of study treatment. |
6. Known severe congenital or acquired coagulation disturbances. |
7. Known renal insufficiency with serum creatinine levels >160 μmol/l. |
8. Known severe hepatic insufficiency with either/or/and serum aspartate aminotransferase activity >54 U/l, serum alanine aminotransferase activity >42 U/l. |
9. Renal dialysis. |
10. Known diabetes mellitus. |
11. Known pregnancy, or lactation, or women of childbearing potential without the use of a reliable contraceptive method. |
12. Known alcohol and/or drug intoxication. |
13. An operation pending which could have limited the possibility to follow up the patient. |
14. Mental disorders or mentally unable to follow exactly the trial instructions. |
15. Previously enrolled in the same trial. |
16. Participation in other clinical trials with an investigational product within the 30 days before the inclusion in this study or participation more than 3 times in other clinical trials with drugs in the 12 months before inclusion. |