Open Label Trial of NanoDOX Hydrogel in Orthopedic Trauma Wounds With and Without Vacuum Assisted Closure Therapy

Inclusion Criteria:

- Be 18 years of age or older

- Women of childbearing potential must have a negative urine pregnancy test at
screening and at baseline

- Agree to use a double-barrier method of contraception during their participation in
this study

- condoms (with spermicide) and hormonal contraceptives OR

- condoms (with spermicide) and intrauterine device OR

- intrauterine device and hormonal contraceptives OR

- Abstains from sexual intercourse during their participation in this study

- Is with a same-sex partner and does not participate in bisexual activities where
there is a risk of becoming pregnant

- Have a full-thickness trauma wound that is between 1.2cm2 and 24cm2 at initial
screening

- Be able to apply study drug to their wound, or have a reliable and capable caregiver
do it

- Subjects will have adequate blood flow to the wound as defined by transcutaneous
oxygen tension (TcpO2) of >30mmHg recorded over intact epidermis at the wound margin.

Exclusion Criteria:

- Less than 18 years of age

- Pregnant or lactating woman or a female of childbearing potential who is not
practicing acceptable form of birth control.

- Allergic to tetracycline, minocycline, demeclocycline, or any other known
tetracycline derivative

- Tested positive for a doxycycline-resistant infection

- Have undergone treatment with systemic corticosteroid or immunosuppressive therapy in
the past 2 months

- Currently undergoing dialysis for renal failure

- Have participated in another clinical research trial within the last 30 days

- Subject has wounds resulting from any cause other than trauma (diabetes, electrical
burn, arterial insufficiency, chemical or radiation insult)

- 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 wound area to be treated by investigational drug or placebo

- 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.

- History of sickle cell anemia

- History of infection with Human Immunodeficiency Virus

- History of other immunodeficiency disorders

- Severe anemia - Hgb < 7 g/dl (males) or < 6.5 (females)