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NCT01284023 · ClinicalTrials.gov registry record
Use of Near Infrared Spectroscopy to Detect Muscle Perfusion in the Lower Extremity of Uninjured Subjects
A clinical trial of Acute Compartment Syndrome, sponsored by J&M Shuler.
- Completed
- Registry status
- 44
- Enrollment target
- 1
- Study location
NCT01284023: Completed study of Acute Compartment Syndrome, sponsored by J&M Shuler.
NCT01284023 is a study of Acute Compartment Syndrome that has completed, run by J&M Shuler. The registered enrollment target is 44 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01284023, a study of Acute Compartment Syndrome, has completed, sponsored by J&M Shuler.
- COMPLETED
- Registry status
- 44 participants
- Enrollment target
- 1
- Study location
Study Summary
Acute compartment syndrome (ACS) is a complication of lower leg trauma that occurs when the pressure inside the leg due to swelling exceeds the body's ability to provide blood to the muscle of the leg. This condition cuts off blood flow to the leg. Left untreated, the condition can result in devastating consequences including complete loss of function of the lower extremity or amputation. Near-infrared spectroscopy (NIRS)-based tissue perfusion monitors are a non-invasive means of continuously monitoring the amount of oxygen in the tissues of an injured extremity. The device utilizes harmless red light to detect the proportion of hemoglobin saturated with oxygen up to 3 cm below the skin surface. The purpose of this study will be to launch the first stages of validation of this device as a diagnostic tool for compartment syndrome, by observing this device in uninjured subjects.
Primary Outcome
Uninjured subjects will lay supine and be monitored for two one hour periods, on separate days.
Conditions Studied
Interventions
- OTHER Shaving
Study Locations (1)
Georgia
- Athens Orthopedic Clinic, PA - Athens
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2011-01 |
| Est. Completion | 2012-08 |
What the finished NCT01284023 record still lists
NCT01284023 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 44 participants, a relatively small participant target.
The record links to 1 condition, with Acute Compartment Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Shaving is the first listed.
NCT01284023 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT01284023 about?
NCT01284023 is a clinical study titled "Use of Near Infrared Spectroscopy to Detect Muscle Perfusion in the Lower Extremity of Uninjured Subjects". Acute compartment syndrome (ACS) is a complication of lower leg trauma that occurs when the pressure inside the leg due to swelling exceeds the body's ability to provide blood to the muscle of the leg. This condition cuts off blood flow to the leg. Left untreated, the condition can result in devasta...
What is the current status of trial NCT01284023?
This trial is currently completed. The enrollment target is 44 participants. The study started on 2011-01. Estimated completion is 2012-08.
What conditions does trial NCT01284023 study?
This clinical trial studies the following conditions: Acute Compartment Syndrome.
What interventions are being tested in trial NCT01284023?
The interventions under investigation include: Shaving (OTHER).
Who is sponsoring clinical trial NCT01284023?
This trial is sponsored by J&M Shuler, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01284023 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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