Trial Outcomes & Findings for The Clinical Efficacy of Next Science Wound Gel (NXTSC) in the Healing of Chronic Wounds (NCT NCT02465073)

NCT ID: NCT02465073

Last Updated: 2019-11-25

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 49 participants
• Primary outcome timeframe: Percentage after 4 weeks
• Results posted on: 2019-11-25

Participant Flow

Participant milestones

Measure	NXTSC This group will receive the NXTSC gel only. NXTSC wound gel: Subjects will receive NXTSC wound gel only.	NXTSC Plus SOC This group will receive the NXTSC wound gel plus Standard of Care. 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 This group will receive Standard of Care only. Standard of Care Group: Subjects will receive Standard of Care only.
Overall Study STARTED	17	16	16
Overall Study COMPLETED	15	15	15
Overall Study NOT COMPLETED	2	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	NXTSC n=15 Participants This group will receive the NXTSC gel only. NXTSC wound gel: Subjects will receive NXTSC wound gel only.	NXTSC Plus SOC n=15 Participants This group will receive the NXTSC wound gel plus Standard of Care. 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 n=15 Participants This group will receive Standard of Care only. Standard of Care Group: Subjects will receive Standard of Care only.	Total n=45 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=93 Participants	13 Participants n=4 Participants	12 Participants n=27 Participants	34 Participants n=483 Participants
Age, Categorical >=65 years	6 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants	11 Participants n=483 Participants
Age, Continuous	57 years n=93 Participants	63 years n=4 Participants	60 years n=27 Participants	60 years n=483 Participants
Sex: Female, Male Female	10 Participants n=93 Participants	8 Participants n=4 Participants	6 Participants n=27 Participants	24 Participants n=483 Participants
Sex: Female, Male Male	5 Participants n=93 Participants	7 Participants n=4 Participants	9 Participants n=27 Participants	21 Participants n=483 Participants
Region of Enrollment United States	15 participants n=93 Participants	15 participants n=4 Participants	15 participants n=27 Participants	45 participants n=483 Participants

PRIMARY outcome

Timeframe: Percentage after 4 weeks

Outcome measures

Measure	NXTSC n=15 Participants This group will receive the NXTSC gel only. NXTSC wound gel: Subjects will receive NXTSC wound gel only.	NXTSC Plus SOC n=15 Participants This group will receive the NXTSC wound gel plus Standard of Care. 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 n=15 Participants This group will receive Standard of Care only. Standard of Care Group: Subjects will receive Standard of Care only.
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	62 percentage of participants	72 percentage of participants	47 percentage of participants

Adverse Events

NXTSC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

NXTSC Plus SOC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Randall Wolcott

Southwest Regional Wound Care Center

Phone: 806-793-8869

Email: randy@randallwolcott.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place