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

NCT02138994 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2017-03-28

No results posted yet for this study

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.

Conditions

  • Wound Chronic Draining

Interventions

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

Sponsors & Collaborators

  • Mayo Clinic

    collaborator OTHER

  • Jacksonville Center For Clinical Research

    collaborator OTHER

  • Next Science TM

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2016-03-31
Completion
2016-09-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02138994 on ClinicalTrials.gov