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OpenTrials
Completed

NCT Number: NCT02465073

The Clinical Efficacy of Next Science Wound Gel (NXTSC) in the Healing of Chronic Wounds

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Southwest Regional Wound Care Center

Lubbock, Texas, 79410, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The subject must have a full-thickness chronic wound for greater than one month.
  • The subject must be at least 18 years of age.
  • The ulcer to be biopsied must be greater than 1 centimeter in area.
  • The subject must be able to give informed consent.

Exclusion criteria

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

Treatment and study plan

NXTSC wound gel

Device

Subjects will receive NXTSC wound gel only.

Other names: NXTSC

NXTSC wound gel plus Standard of Care

Device

Subjects will be randomized to the NXTSC wound gel plus Standard of Care of only.

Other names: NXTSC + SOC

Standard of Care Group

Device

Subjects will receive Standard of Care only.

Other names: SOC

Primary outcomes

  1. 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

    Time frame: Percentage after 4 weeks

Sponsors and collaborators

Lead sponsor

Southwest Regional Wound Care Center

Other

Collaborators

  • Next Science TM

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 8, 2015
Registry last updated
Nov 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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