Trial Outcomes & Findings for Application of Indocyanine Green Angiography for Closed Operative Calcaneus Fractures (NCT NCT01693484)

Last Updated: 2017-06-20

Results Overview

correlation of multiple absolute and relative data points acquired from near infra red spectroscopy compared to clinical postoperative infection or wound healing complication following lateral approach calcaneus fracture

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

13 participants

Primary outcome timeframe

3 months postoperative

Results posted on

2017-06-20

Participant Flow

Participant milestones

Participant milestones
Measure	Displaced Intra Articular Calcaneus Fracture displaced intra articular calcaneus fracture with operative repair
Overall Study STARTED	13
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Application of Indocyanine Green Angiography for Closed Operative Calcaneus Fractures

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Operative Calcaneus Fracture n=13 Participants Patients with indications for and electing to undergo operative repair of intra articular calcaneus fracture through extended lateral approach
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months postoperative

Population: unable to complete analysis as correlation between clinical and ICG near infra red data acquisition could not be completed do to unexpected lack funding required to pair and analyze extremely large data sets with clinical information as well as too few numbers of patients

Outcome measures

Outcome data not reported

Adverse Events

Unanticipated Adverse Events Related to ICG

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Unanticipated Adverse Events Related to ICG n=13 participants at risk No adverse events related to administration ICG
Skin and subcutaneous tissue disorders wound healing delay	46.2% 6/13 • Number of events 6

Additional Information

Dr Todd Jaeblon

LSU Health Science Center Shreveport

Phone: 318 675 6180

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place