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

Overview

  • Study type

    Interventional
  • Study phase

    II
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Jacksonville, Florida: 14-003340
    NCT ID: NCT02138994
    Sponsor Protocol Number: CSP-001

About this study

This is a 3 to 4 months, single 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).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status

Jacksonville, Fla.

Mayo Clinic principal investigator

Albert Hakaim, M.D.

Closed for enrollment

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CLS-20144033

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