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

Primary Purpose

Orthopedic Trauma Wounds

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NanoDOX Hydrogel
VAC Alone
Sponsored by
NanoSHIFT LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Orthopedic Trauma Wounds

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Walter Reed National Military Medical Center
  • Univeristy of Missouri

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NanoDOX Hydrogel plus VAC

VAC Alone

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Determine the effect of NanoDOX Hydrogel on the healing rates of open traumatic orthopedic wounds with and without vacuum assisted closure therapy.
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.

Secondary Outcome Measures

Analyze the molecular changes in proinflammatory cytokine levels and bioburden that occur in traumatic orthopedic and soft tissue wounds
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.

Full Information

First Posted
January 18, 2012
Last Updated
June 21, 2017
Sponsor
NanoSHIFT LLC
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT01518491
Brief Title
Open Label Trial of NanoDOX Hydrogel in Orthopedic Trauma Wounds With and Without Vacuum Assisted Closure Therapy
Official Title
A Prospective, Randomized, Open Label Trial of NanoDOX™ Hydrogel Plus Vacuum Assisted Closure Therapy Versus Vacuum Assisted Closure Therapy Alone in Orthopedic Trauma Wounds.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Withdrawn
Study Start Date
April 2012 (undefined)
Primary Completion Date
October 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NanoSHIFT LLC
Collaborators
United States Department of Defense

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthopedic Trauma Wounds

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NanoDOX Hydrogel plus VAC
Arm Type
Experimental
Arm Description
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.
Arm Title
VAC Alone
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
NanoDOX Hydrogel
Intervention Description
NanoDOX Hydrogel will be applied three time weekly to the wound for eight weeks along with VAC therapy
Intervention Type
Other
Intervention Name(s)
VAC Alone
Intervention Description
Patients will receive VAC therapy three time weekly for eight weeks
Primary Outcome Measure Information:
Title
Determine the effect of NanoDOX Hydrogel on the healing rates of open traumatic orthopedic wounds with and without vacuum assisted closure therapy.
Description
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.
Time Frame
participants will be followed for up to eight weeks
Secondary Outcome Measure Information:
Title
Analyze the molecular changes in proinflammatory cytokine levels and bioburden that occur in traumatic orthopedic and soft tissue wounds
Description
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.
Time Frame
participants will have three visits per week for up to eight weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Abernethy, MD
Organizational Affiliation
Ology Bioservices
Official's Role
Study Director
Facility Information:
Facility Name
Walter Reed National Military Medical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889
Country
United States
Facility Name
Univeristy of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States

12. IPD Sharing Statement

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

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