Status:
WITHDRAWN
Open Label Trial of NanoDOX Hydrogel in Orthopedic Trauma Wounds With and Without Vacuum Assisted Closure Therapy
Lead Sponsor:
NanoSHIFT LLC
Collaborating Sponsors:
United States Department of Defense
Conditions:
Orthopedic Trauma Wounds
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the effect of NanoDOX™ Hydrogel in conjunction with serial wound debridement and irrigation on the healing rates of open traumatic orthopedic and soft tissue ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01518491
Start Date
April 1 2012
End Date
December 1 2012
Last Update
June 23 2017
Active Locations (2)
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1
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
2
Univeristy of Missouri
Columbia, Missouri, United States, 65212