Trial Outcomes & Findings for Topical Nitric Oxide Trial in Chronic Non-Healing Wounds (NCT NCT00823095)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

7 participants

Primary outcome timeframe

at 28 days post enrollment

Results posted on

2016-02-26

Participant milestones
Measure	Topically Applied Nitric Oxide Topically applied gaseous nitric oxide at 8 to 10 parts per million, for 8 hours each night for 14 nights.
Overall Study STARTED	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Topical Nitric Oxide Trial in Chronic Non-Healing Wounds

Baseline characteristics by cohort
Measure	Group 1 n=7 Participants Treatment
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants
Evidence of a colonized wound on the lower extremity. >=65 years	4 participants n=5 Participants
Evidence of a colonized wound on the lower extremity. 18 to 65 years	3 participants n=5 Participants

Timeframe: at 28 days post enrollment

Population: Data not available for this study due to dissolution of company contracted to perform study analysis

Outcome data not reported

Timeframe: 28 days post enrollment

Population: Data not available for this study due to dissolution of company contracted to perform analysis.

reduction in bioburden as assessed by number of cfu's per cm2 on culture

Outcome data not reported

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Loma Linda University Medical Center

Phone: (909) 558-4000