Trial Outcomes & Findings for Treatment of Vasopressor-induced Ischemia With Botulinum Toxin A (NCT NCT01483209)

NCT ID: NCT01483209

Last Updated: 2015-03-02

Results Overview

A paired T-test will be used to compare pre- and post-injection Laser Doppler measurements for the experimental hand. We will again use a paired t-test to compare the experimental hand against the contralateral control hand. Results for the experimental and control groups will be plotted and displayed graphically as percent change in Doppler flow (y-axis) and time (x-axis).

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 2 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2015-03-02

Participant Flow

Participant milestones

Measure	Boxtox Injection Subjects will serve as their own controls. Both hands are evaluated and the hand demonstrating more severe ischemia will be the one to receive the Botox (experimental treatment).
Overall Study STARTED	2
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Vasopressor-induced Ischemia With Botulinum Toxin A

Baseline characteristics by cohort

Measure	Boxtox Injection n=2 Participants Subjects will serve as their own controls. Both hands are evaluated and the hand demonstrating more severe ischemia will be the one to receive the Botox (experimental treatment).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Due to insufficient accrual, data analysis was not performed.

A paired T-test will be used to compare pre- and post-injection Laser Doppler measurements for the experimental hand. We will again use a paired t-test to compare the experimental hand against the contralateral control hand. Results for the experimental and control groups will be plotted and displayed graphically as percent change in Doppler flow (y-axis) and time (x-axis).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Population: Due to insufficient accrual, data analysis was not performed.

The number of digits amputated in our patient cohort is a secondary endpoint of this study. We will use a paired t-test to compare the number of digital amputations in the control versus experimental group.

Outcome measures

Outcome data not reported

Adverse Events

Botox Injection

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

Dr. Cynthia Shortell

Duke University Medical Center

Phone: 919-681-2223

Email: cynthia.shortell@duke.edu

Results disclosure agreements

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