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

Not Applicable

Completed

Interventions: Device: NXTSC wound gel
Device: NXTSC wound gel plus Standard of Care
Device: Standard of Care Group

Brief 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.

Detailed 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 & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
NXTSC	NXTSC wound gel	This group will receive the NXTSC gel only. The NXTSC wound gel and its active agents are applied on the wound bed. A synthetic microfiber dressing will be applied to the surface of the wound. Determine the effect on wound treatment outcomes using a novel antimicrobial wound gel for the treatment of infected wounds as the sole topical treatment of microbial infection at the wound site. ( NXTSC).
NXTSC plus SOC	NXTSC wound gel plus Standard of Care	This group will receive the NXTSC wound gel plus Standard of Care. The NXTSC wound gel is applied to the wound bed. Local wound management will consist of diagnosing the wound biofilm and providing specific measures to suppress the wound biofilm to allow host healing. 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.( Next Science Wound Gel, plus standard of care).
SOC	Standard of Care Group	This group will receive Standard of Care only. The Standard of Care is based on wound management intervention to remove wound slough by frequent debridement. Moist interactive wound care with multiple strategies to suppress biofilm is instituted. Determine the effect on wound treatment outcomes using standard of care treatment

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures