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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Nanotherapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01518491
First received: January 18, 2012
Last updated: June 6, 2013
Last verified: June 2013

January 18, 2012
June 6, 2013
April 2012
October 2012   (final data collection date for primary outcome measure)
Determine the effect of NanoDOX Hydrogel on the healing rates of open traumatic orthopedic wounds with and without vacuum assisted closure therapy. [ Time Frame: participants will be followed for up to eight weeks ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01518491 on ClinicalTrials.gov Archive Site
Analyze the molecular changes in proinflammatory cytokine levels and bioburden that occur in traumatic orthopedic and soft tissue wounds [ Time Frame: participants will have three visits per week for up to eight weeks ] [ Designated as safety issue: Yes ]
Analyze the molecular changes in proinflammatory cytokine levels and bioburden (quantitative bacteriology and qRT-PCR for 16S rDNA) that occur in traumatic orthopedic and soft tissue wounds as a function of healing rate in the presence/absence of NanoDOX™ Hydrogel.
Same as current
Not Provided
Not Provided
 
Open Label Trial of NanoDOX Hydrogel in Orthopedic Trauma Wounds With and Without Vacuum Assisted Closure Therapy
A Prospective, Randomized, Open Label Trial of NanoDOX™ Hydrogel Plus Vacuum Assisted Closure Therapy Versus Vacuum Assisted Closure Therapy Alone in Orthopedic Trauma Wounds.

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Orthopedic Trauma Wounds
  • Drug: NanoDOX Hydrogel
    NanoDOX Hydrogel will be applied three time weekly to the wound for eight weeks along with VAC therapy
  • Other: VAC Alone
    Patients will receive VAC therapy three time weekly for eight weeks
  • Experimental: NanoDOX Hydrogel plus VAC
    NanoDOX™ Hydrogel in conjunction with serial wound debridement and irrigation on open traumatic orthopedic and soft tissue wounds in patients receiving negative pressure wound therapy/vacuum assisted closure (NPWT/VAC) with reticulated open cell foam (ROCF) dressings.
    Intervention: Drug: NanoDOX Hydrogel
  • Active Comparator: VAC Alone
    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.
    Intervention: Other: VAC Alone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
December 2012
October 2012   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01518491
2009-DOX-NT/009
No
Nanotherapeutics, Inc.
Nanotherapeutics, Inc.
Department of Defense
Study Director: John Abernethy, MD Nanotherapeutics, Inc.
Nanotherapeutics, Inc.
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP