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

Next Science TM43 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Wound Chronic Draining

Interventions

Next Science Wound GelDEVICE

Triple Antibiotic Ointment NeosporinDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Mayo Clinic Florida

Jacksonville, Florida, United States

Jacksonville Center for Clinical Research - RCCR location

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

Wound Size Reduction

Time frame: 2, 4, 8 and 12 weeks

Secondary Outcomes

Wound Closure

Time frame: 2, 4, 8 and 12 weeks

Data from ClinicalTrials.gov

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