Ignite Creation Date:
2025-12-25 @ 1:35 AM
Ignite Modification Date:
2025-12-25 @ 11:56 PM
Study NCT ID:
NCT02138994
Status:
COMPLETED
Last Update Posted:
2017-03-28
First Post:
2014-05-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Next Science Wound Gel Efficacy in Chronic Wound Versus Standard of Care
Sponsor:
Next Science TM
Organization:
Study Overview
Official Title:
Clinical Assessment of the Next Science Wound Gel Efficacy in Chronic Wound Compared to Standard of Care
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: