Trial Outcomes & Findings for MRI Results in Dupuytren's Contracture Before and After Injection With Xiaflex (NCT NCT01450397)

Results Overview

Change in Volume (millimeter cubed) of the Cord by MRI between Baseline and 30 days after XIAFLEX injection and manual manipulation.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

5 participants

Primary outcome timeframe

Baseline and 30 days

Results posted on

2017-04-17

Subjects were enrolled from July 2011 to December 2011. Enrollment was completed in a medical clinic.

Participant milestones
Measure	XIAFLEX 0.58 mg of Xiaflex injected into a palpable Dupuytren's cord
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Withdrawal data not reported

MRI Results in Dupuytren's Contracture Before and After Injection With Xiaflex

Baseline characteristics by cohort
Measure	XIAFLEX n=5 Participants Patient who have received XIAFLEX
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=99 Participants
Age, Categorical >=65 years	4 Participants n=99 Participants
Age, Continuous	67.6 years STANDARD_DEVIATION 5.5 • n=99 Participants
Sex: Female, Male Female	0 Participants n=99 Participants
Sex: Female, Male Male	5 Participants n=99 Participants
Region of Enrollment United States	5 participants n=99 Participants

Timeframe: Baseline and 30 days

Change in Volume (millimeter cubed) of the Cord by MRI between Baseline and 30 days after XIAFLEX injection and manual manipulation.

Outcome measures
Measure	XIAFLEX n=5 Participants Subjects receiving one Xiaflex injection
The Measured Change in Volume of the Cord by MRI Before and After XIAFLEX Injection and Manual Manipulation.	482 mm^3 Interval 188.0 to 670.0

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

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