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

Timely return of combat wounded to functional lives and duty is imperative. Reliance upon
traditional wound management principles is restrictive, and a treatment paradigm aimed at
high-energy projectile contaminated wounds suits the requirements of our combat casualty
care program. The nature of war wounds makes them unsuitable for conventional,
saline-soaked-gauze dressings.

Extra-corporeal-shockwave-therapy (ESWT) has been used successfully for orthopedic soft
tissue indications. Pilot studies indicate that ESWT enhances tissue healing through
growth-factor release and neovascularization, with favorable safety profile and
anti-bacterial effect, particularly in problematic wounds including fracture non-unions,
post-traumatic wounds, and burns.

The need to improve the healing and quality-of-life of the combat wounded, the potential of
this minimal-risk technology to improve healing of difficult-to-treat orthopedic/soft tissue
injury and infection, as well as the combat casualty care experience of surgeons at WRAMC,
dovetail uniquely to have our wounded soldiers and medical center play a pivotal role as the
fundamental proving ground and primary beneficiary of this technology.

Comparison(s): Standard-of-care wound therapy compared to standard-of-care wound therapy +
ESWT for extremity wounds with the aim of conducting a definitive critical analysis of the
role of ESWT in improved treatment and outcomes of traumatic soft tissue injuries of the
extremity.

Inclusion Criteria:

- Patients should be 18 years of age or older, and capable of providing informed
consent indicating awareness of the investigational nature of this trial, in keeping
with institutional policy.

- Written informed consent must be obtained from each patient prior to entering the
study.

- Female patients will not be pregnant. Exclusion of the possibility of pregnancy by
HCG testing (urine or serum) or by history (tubal ligation, hysterectomy, or
menopause) is required prior to inclusion in the study.

- Patients should be willing to be followed within the military healthcare system, or
the participating civilian center during the course of study treatment and follow-up.

- Patients with traumatic wound(s) of the upper and/or lower extremity. The study wound
is the wound with the highest Red Cross Wound Classification (RCWC).

- Patients should demonstrate adequacy of limb perfusion by all of the following
clinical parameters in the affected extremity to be treated by investigational shock
wave therapy: Palpable distal extremity pulse; Absence of compartment syndrome; or
Ankle Brachial Index(ABI) ≥ 0.9 or transcutaneous pulse oximetry, tcP02≥20mmHg.

- Patients with non-circumferential, second degree burn wounds of the upper and/or
lower extremity.

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.