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NCT02228057 · ClinicalTrials.gov registry record

Long Term Patency Following Arterial Repair

A clinical trial, sponsored by University of Pittsburgh.

Completed
Registry status
13
Enrollment target

NCT02228057 is a clinical trial that has completed, run by University of Pittsburgh. The registered enrollment target is 13 participants.

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The verdict

NCT02228057 has completed, sponsored by University of Pittsburgh.

COMPLETED
Registry status
13 participants
Enrollment target

Study Summary

Injury to the blood vessels of the extremities, and more specifically the arteries, can result from fractures and severe crush injuries. It occurs in about 3% of the general population. People affected by blood vessel injuries can have important problems, including cold intolerance, general pain, and weakened function of the associated limb. Even after surgical intervention to repair the affected artery, people may still experience numbness, problems with movement, and an inadequate supply of oxygen to the limb. These symptoms are particularly relevant in the case of forearm arterial repairs because this repair directly affects one of our most vital structures: the hand. Despite available interventions and advances in microsurgical technique, arterial repairs can still result in significant sensory and functional impairment of the hand. Once an artery within the arm is injured, a surgeon's primary goal is to restore blood flow to the hand and prevent functional impairment. Even with a prompt effort to restore hand perfusion, long-term (greater than 6 months) sensory and motor function is hard to predict. Furthermore, sometimes the repaired artery becomes occluded over time. We believe that this occlusion has a direct impact on a patient's perceived pain and cold intolerance at the level of the hand. In this study, we are investigating the occurrence of blood vessel occlusion in the arm after at least 6 months of surgery and the impact of this event. To assess this we will use physical exams, non-invasive tests, duplex doppler ultrasound and questionnaires. Questionnaires, including the DASH (disabilities of the arm, shoulder,and hand), CISS (Cold Intolerance Symptom Severity Questionnaire), and Michigan hand score, will be used to assess pain, sensory, and motor impairments in both the affected and unaffected hand. Functional assessments will include 2-point discrimination, grip strength, pinch strength, capillary refill and range of motion.

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2014-08
Est. Completion 2015-02

Sponsor

University of Pittsburgh

1,238 total trials

What the Registry Record Tells You About NCT02228057

The ClinicalTrials.gov registry entry for NCT02228057 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 0 interventions.

NCT02228057 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02228057 about?

NCT02228057 is a clinical study titled "Long Term Patency Following Arterial Repair". Injury to the blood vessels of the extremities, and more specifically the arteries, can result from fractures and severe crush injuries. It occurs in about 3% of the general population. People affected by blood vessel injuries can have important problems, including cold intolerance, general pain, an...

What is the current status of trial NCT02228057?

This trial is currently completed. The enrollment target is 13 participants. The study started on 2014-08. Estimated completion is 2015-02.

Who is sponsoring clinical trial NCT02228057?

This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.

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