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NCT01522495 · ClinicalTrials.gov registry record · NA

Pilot Study to Determine Percent Tissue Perfusion and Cellular Viability Using SPY Imaging

A NA study, sponsored by Georgetown University.

Completed
Registry status
NA
Development phase
31
Enrollment target

NCT01522495: Completed NA study, sponsored by Georgetown University.

NCT01522495 is a NA study that has completed, run by Georgetown University. The registered enrollment target is 31 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01522495, a NA study, has completed, sponsored by Georgetown University.

COMPLETED
Registry status
NA
Development phase
31 participants
Enrollment target

Study Summary

Little is known about chronic wound microenvironments, especially in peripheral vascular disease (PVD) and diabetic patients. At the demarcation line, the percentage of viable cells and tissue is unclear. A means to determine cell viability, particularly discerning an apoptotic or necrotic cell pathway would indicate where the line of demarcation should be drawn. The information generated would better predict clinical outcome using SPY Imaging. Cellular studies are needed to successfully confirm a clear line of demarcation to eliminate surgeon subjectivity.

Primary Outcome

Determine percent cellular viability (vs. apoptotic/dead) of cells at demarcation line

Interventions

  • DEVICE SPY Imaging, ICG dye (0.2 - 0.5 mg/kg)
  • DEVICE SPY Imaging

Trial Details

FieldValue
Enrollment Target 31 participants
Start Date 2013-04
Est. Completion 2019-12
Phase NA
Georgetown University

227 total trials

What the finished NCT01522495 record still lists

NCT01522495 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 2 interventions - of which SPY Imaging, ICG dye (0.2 - 0.5 mg/kg) is the first listed.

NCT01522495 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01522495 about?

NCT01522495 is a clinical study titled "Pilot Study to Determine Percent Tissue Perfusion and Cellular Viability Using SPY Imaging". Little is known about chronic wound microenvironments, especially in peripheral vascular disease (PVD) and diabetic patients. At the demarcation line, the percentage of viable cells and tissue is unclear. A means to determine cell viability, particularly discerning an apoptotic or necrotic cell path...

What is the current status of trial NCT01522495?

This trial is currently completed. It is a NA study. The enrollment target is 31 participants. The study started on 2013-04. Estimated completion is 2019-12.

What interventions are being tested in trial NCT01522495?

The interventions under investigation include: SPY Imaging, ICG dye (0.2 - 0.5 mg/kg) (DEVICE), SPY Imaging (DEVICE).

Who is sponsoring clinical trial NCT01522495?

This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01522495's enrollment target sits among peer trials

31 1592nd of 2000 higher than 408 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01522495, the US trial registry maintained by the National Library of Medicine. NCT01522495 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.