Orthopedic Trauma WoundsPhase 2NCT01518491
Open Label Trial of NanoDOX Hydrogel in Orthopedic Trauma Wounds With and Without Vacuum Assisted Closure Therapy
A Phase 2 study testing NanoDOX Hydrogel and VAC Alone in people with Orthopedic Trauma Wounds, run by NanoSHIFT LLC at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthopedic Trauma Wounds
- What is being tested?
- NanoDOX Hydrogel and VAC Alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2012to Dec 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
Univeristy of Missouri
Columbia, Missouri, 65212
About this study
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.
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.
- Conditions
- Orthopedic Trauma Wounds
- Being tested
- NanoDOX Hydrogel, VAC Alone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NanoDOX HydrogelDrug
NanoDOX Hydrogel will be applied three time weekly to the wound for eight weeks along with VAC therapy
VAC AloneOther
Patients will receive VAC therapy three time weekly for eight weeks
| Study group | Role | What they receive |
|---|---|---|
| NanoDOX Hydrogel plus VAC | Experimental | 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. Receives: Drug: NanoDOX Hydrogel |
| VAC Alone | Active comparator | 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. Receives: Other: VAC Alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: participants will be followed for up to eight weeks
Secondary outcomes (1)
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.
Measured: participants will have three visits per week for up to eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2012 (estimated)
- Study startApr 2012
- Primary completionOct 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic Trauma WoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NanoSHIFT LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- John Abernethy, MD, Study director, Alachua Government Services, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01518491
- Sponsor's protocol ID
- 2009-DOX-NT/009
- Status last verified
- Jun 2017
- First submitted
- 18 Jan 2012
- Last updated
- 23 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01518491
- Acronym / sponsor ID
- 2009-DOX-NT/009
- Conditions
- Orthopedic Trauma Wounds
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NanoSHIFT LLCIndustry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Study start
- Apr 2012
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 26 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NanoDOX Hydrogel plus VAC | Experimental | Drug: NanoDOX HydrogelNanoDOX™ 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. |
| VAC Alone | Active comparator | Other: VAC AloneSerial wound debridement and irrigation alone in patients receiving negative pressure wound therapy/vacuum assisted closure (NPWT/VAC) with reticulated open cell foam (ROCF) dressings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NanoDOX HydrogelNanoDOX Hydrogel will be applied three time weekly to the wound for eight weeks along with VAC therapy | Drug | NanoDOX Hydrogel plus VAC |
| VAC AlonePatients will receive VAC therapy three time weekly for eight weeks | Other | VAC Alone |
Primary outcome
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
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.
1 secondary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Abernethy, MD study director
Alachua Government Services, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NanoDOX Hydrogel and VAC Alone in people with Orthopedic Trauma Wounds, run by NanoSHIFT LLC at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2017.