Summary:
Approximately 1/3 of people with peripheral arterial disease typically suffer from pain in one or both legs during walking (primarily in the calves), which does not vanish with continued walking and is relieved by rest. This symptom is known as claudication. In a certain group of patients with claudication, the severity of the condition increases gradually until it develops into critical limb ischemia (CLI); the end stage of the disease.
This is a prospective, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of autologous ACPs administered intramuscularly into the gastrocnemius and dorsal foot muscles of one affected limb in subjects with CLI with no surgical or endovascular recascularization options.
Qualified Participants Must:
• Be diagnosed with CLI
•
Not a candidate for revascularization for peripheral arterial disease and amputation of limb is only remaining option
Qualified Participants May Receive:
- Compensation for time and travel expenses
- Study related care and blood work
- Physicals performed by a board certified physician