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

Withdrawn before enrolling · Phase 2

Conditions studied: Orthopedic Trauma Wounds

In brief

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 wounds when compared to a serial wound debridement and irrigation alone in patients receiving negative pressure wound therapy/vacuum assisted closure (NPWT/VAC) with reticulated open cell foam (ROCF) dressings.

Key facts

Study ID

NCT01518491

Run by

NanoSHIFT LLC

People needed

0

Starts

2012-04-01

Expected to finish

2012-12-01

Last updated by the study team

2017-06-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• Walter Reed National Military Medical Center — Bethesda, Maryland, United States
• Univeristy of Missouri — Columbia, Missouri, United States

Full record on ClinicalTrials.gov

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