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Next Science Wound Gel Efficacy in Chronic Wound Versus Standard of Care

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ClinicalTrials.gov Identifier: NCT02138994
Recruitment Status : Completed
First Posted : May 15, 2014
Last Update Posted : March 28, 2017
Sponsor:
Collaborators:
Mayo Clinic
Jacksonville Center For Clinical Research
Information provided by (Responsible Party):
Next Science TM

Tracking Information
First Submitted Date  ICMJE May 12, 2014
First Posted Date  ICMJE May 15, 2014
Last Update Posted Date March 28, 2017
Study Start Date  ICMJE July 2014
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2014)
Wound Size Reduction [ Time Frame: 2, 4, 8 and 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02138994 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2014)
Wound Closure [ Time Frame: 2, 4, 8 and 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 13, 2014)
Reduction of bacterial species types and amounts [ Time Frame: 0 and 4 weeks ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Next Science Wound Gel Efficacy in Chronic Wound Versus Standard of Care
Official Title  ICMJE Clinical Assessment of the Next Science Wound Gel Efficacy in Chronic Wound Compared to Standard of Care
Brief Summary This is a 3 to 4 months, multi-site, prospective randomized clinical study of patients diagnosed with a chronic wound. The primary objective is to assess changes in healing rate, by measuring differences in wound area when treating chronic wounds with the Next Science Wound Gel compared to the Triple Antibiotic Ointment Neosporin (Standard of Care, SOC). At the end of the study period, patients may continue receiving their assigned study treatment provided they have signed the "Continuation of Treatment Informed Consent" and the rational for continuation is documented by the investigator.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Wound Chronic Draining
Intervention  ICMJE
  • Device: Next Science Wound Gel
  • Drug: Triple Antibiotic Ointment Neosporin

    Subjects randomized to Neosporin will be required to complete 1 month of treatment comprising a screening/baseline, 2-week and 1-month visits. After 1 month the following may occur based on wound progression and/or the investigator's clinical judgment:

    • Subject may continue the application of Neosporin until wound closure or
    • Subject may cross over to the treatment group for 3 months
Study Arms  ICMJE
  • Active Comparator: Triple Antibiotic Ointment Neosporin
    Daily direct application to the wound, covered with conventional dressing. Dressing should be changed daily or as directed by the health care provider.
    Intervention: Drug: Triple Antibiotic Ointment Neosporin
  • Experimental: Next Science Wound Gel
    Daily direct application to the wound, covered with a conventional non-alginate dressing. Dressing should be changed daily or as directed by the health care provider.
    Intervention: Device: Next Science Wound Gel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 9, 2016)
43
Original Estimated Enrollment  ICMJE
 (submitted: May 13, 2014)
30
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female 18 years or older
  • Presence of full-thickness wound for more than one month (i.e. chronic)
  • Ulcer must be greater than 1 centimeter in area to enable biofilm sampling
  • NOT a candidate for vascular reconstructive surgery to restore blood flow to the wound
  • Willing to comply with all study procedures and be available for the duration of the study
  • Provide signed and dated informed consent

Exclusion Criteria:

  • Subjects unable to provide signed and dated informed consent
  • Male or female less than 18 years old
  • Presence of a full-thickness wound for less than one month
  • A candidate for vascular reconstructive surgery to restore blood flow to the wound
  • Subjects with bleeding dyscrasia or with medical conditions that would make a bleeding complication likely
  • Subjects who's wound is less than 1 cm precluding adequate wound biofilm sampling
  • Subject with known allergic reaction to the study products
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02138994
Other Study ID Numbers  ICMJE CSP-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Next Science TM
Study Sponsor  ICMJE Next Science TM
Collaborators  ICMJE
  • Mayo Clinic
  • Jacksonville Center For Clinical Research
Investigators  ICMJE Not Provided
PRS Account Next Science TM
Verification Date March 2017

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