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OpenTrials
Completed

NCT Number: NCT02138994

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

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.

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Key information

Conditions

Wound Chronic Draining

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jacksonville Center for Clinical Research - RCCR location, Jacksonville, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Next Science Wound Gel

Device

Triple Antibiotic Ointment Neosporin

Drug

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

Primary outcomes

  1. Wound Size Reduction

    Time frame: 2, 4, 8 and 12 weeks

Secondary outcomes

  1. Wound Closure

    Time frame: 2, 4, 8 and 12 weeks

Other outcomes

  1. Reduction of bacterial species types and amounts

    Time frame: 0 and 4 weeks

Sponsors and collaborators

Lead sponsor

Next Science TM

Industry

Collaborators

  • Jacksonville Center For Clinical Research
  • Mayo Clinic

Registry information

Official study title

Clinical Assessment of the Next Science Wound Gel Efficacy in Chronic Wound Compared to Standard of Care

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 15, 2014
Registry last updated
Mar 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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