Participants included in the study must:
- Have type 1 or type 2 diabetes mellitus.
- Have problems with the nerves in their feet.
- Have a large ulcer or multiple ulcers on the bottom surface of their foot that has
been present for 3 weeks or more and is of sufficient size to qualify for the study.
- Be able to apply study drug to their ulcer, or have a caregiver do it.
- Be able to visit the doctor regularly during the 4½ month study.
Participants may not participate in the study if:
- Their ulcer is caused by bad blood flow to their foot.
- Their ulcer is infected.
- They cannot wear an off-loading device during the study to take pressure off the
- They have certain other diseases, or are using certain types of drugs.