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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02465073
Other study ID # 56-RW-027
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2013
Est. completion date March 2015

Study information

Verified date November 2019
Source Southwest Regional Wound Care Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Determine the effect on wound treatment outcomes using a novel antimicrobial wound gel (NXTSC) for the treatment of infected wounds as the sole topical treatment of microbial infection at the wound site.


Description:

1. Determine the effect on wound treatment outcomes using a novel antimicrobial wound gel (NXTSC) for the treatment of infected wounds as the sole topical treatment of microbial infection at the wound site.

2. Determine the effect on wound treatment outcomes using a novel antimicrobial wound gel for the treatment of infected wounds when this gel is used in conjunction with the current standard of care infection controls to treat microbial infection at the wound site.

3. Determine the effect on wound treatment outcomes using standard of care treatment. (SOC).


Recruitment information / eligibility

Status Completed
Enrollment 49
Est. completion date March 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. The subject must have a full-thickness chronic wound for greater than one month.

2. The subject must be at least 18 years of age.

3. The ulcer to be biopsied must be greater than 1 centimeter in area.

4. The subject must be able to give informed consent.

Exclusion Criteria:

1. Medical or emotional risk associated with the potential biopsy that outweighs the risk of not taking a biopsy as determined by the investigator.

2. Those patients that have significant contributions from other disease processes such as arterial disease (Ankle Brachial Index [ABI] less than .7, OR Transcutaneous Partial Oxygen Pressure [TCpO2 ] less than 20) will be considered to have mixed vascular disease producing their wound and will be excluded from the study.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
NXTSC wound gel
Subjects will receive NXTSC wound gel only.
NXTSC wound gel plus Standard of Care
Subjects will be randomized to the NXTSC wound gel plus Standard of Care of only.
Standard of Care Group
Subjects will receive Standard of Care only.

Locations

Country Name City State
United States Southwest Regional Wound Care Center Lubbock Texas

Sponsors (2)

Lead Sponsor Collaborator
Southwest Regional Wound Care Center Next Science TM

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Percentage of Patients Who Had a 50% or Greater Wound Size Volume Reduction After 4 Weeks of Treatment With the Next Science Wound Gel, as Compared to Wounds Treated With Standard of Care Percentage after 4 weeks
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