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

Study Overview
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Brief Summary
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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.

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

Conditions
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Wound Chronic Draining

Intervention / Treatment
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* Device: Next Science Wound Gel
* Drug: Triple Antibiotic Ointment Neosporin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Triple Antibiotic Ointment Neosporin<br>Daily direct application to the wound, covered with conventional dressing. Dressing should be changed daily or as directed by the health care provider. | Drug: Triple Antibiotic Ointment Neosporin<br>* 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<br>|
| Experimental: Next Science Wound Gel<br>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. | Device: Next Science Wound Gel<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Size Reduction |  | 2, 4, 8 and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Closure |  | 2, 4, 8 and 12 weeks |