Study to Determine if Shock Wave Therapy Applied to Traumatic Wounds of the Extremity Improves Healing Time

Exclusion Criteria

• •Patients with current participation in another clinical investigation of a medical device or a drug the requirements of which may preclude complete involvement in this study.
• •Women who are pregnant.
• •One or more of the following findings in the affected extremity to be treated by investigational shock wave therapy: Ankle Brachial Index \< 0.9 or tcP02\<20 mmHg; Significant arterial or venous injury requiring surgical intervention; or Lymphedema.
• •Subject has another non-superficial wound near the study wound that is less than 3cm from the study wound or that has a RCWC of 3.
• •Active or previous (within 60 days prior to the study screening visit) chemotherapy.
• •Active or previous (within 60 days prior to the study screening visit) radiation to the affected extremity to be treated by investigational shock wave therapy.
• •Physical or mental disability or geographical concerns (residence not within reasonable travel distance) that would hamper compliance with required study visits.
• •The Investigator believes that the subject will be unwilling or unable to comply with study protocol requirements, including the shock wave treatment procedure, standard-of-care self-care requirements, and all study-related follow up visit requirements.
• •Patients with 1st degree, 3rd degree, or circumferential extremity burns considered for treatment by investigational shock wave therapy.
• •History of sickle cell anemia.
• •History of infection with Human Immunodeficiency Virus.
• •History of immunodeficiency disorders.
• •Severe anemia - Hgb \< 7 g/dl (males) or \< 6.5 (females).
• •Deep vein thrombosis within 6 months of study screening visit.
• •Chronic renal insufficiency requiring dialysis.