Wound Healing of Foot and Lower Leg Ulcers

The study will look at the safety and effectiveness of an investigational study medication compared with placebo (no active ingredients), given by injection, to adults ages 18 years or older who have ulcers on the lower leg or foot due to peripheral artery disease (PAD).

What will happen during the study?

If you are eligible and decide to join this study, your participation will last approximately 12 months. During this time, you will receive injections of the investigational product or placebo once a month for 4 months in addition to standard wound care to treat your ulcer. Study site doctors and nurses experienced in clinical trials will monitor your health throughout the study.

During the study, you will also be asked to do the following:

• Answer questions about your health
• Provide urine and blood samples at some study visits
• Follow directions from the study staff
• Attend all scheduled study visits

Eligibility

• Subjects must be 18 years and older
• Subject must have Diabetes Type I or II
• Subject's ulcer must be located on the foot
• Subject's ulcer must extend beyond the dermis of the skin
• Subject must present with signs, symptoms leading to a clinical suspicion of Osteomyelitis.

Eligible participants will receive

• Study-related care and monitoring by a healthcare team
• Potential access to investigational medication at no charge
• Education about condition
• Opportunity to help those with foot ulcers due to PAD in the future

Contact

Jacque Ortiz
847-578-8423