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NCT02202668 · ClinicalTrials.gov registry record · NA

Transcutaneous Raman Spectroscope (TRS) Analyses of Diabetic Foot Ulcers

A NA study, sponsored by University of Michigan.

Terminated
Registry status
NA
Development phase
5
Enrollment target

NCT02202668: Clinical Trial NA study, sponsored by University of Michigan.

NCT02202668 is a NA study that was terminated before completion, run by University of Michigan. The registered enrollment target is 5 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02202668, a NA study, was terminated before completion, sponsored by University of Michigan.

TERMINATED
Registry status
NA
Development phase
5 participants
Enrollment target

Study Summary

The primary translational research objective of the study is to demonstrate feasibility of using the Transcutaneous Raman Spectroscopy technology in a point-of-care environment. This study represents an initial evaluation of the device in a small cohort of human patients with diabetic foot ulcers. We will be evaluating safety, device design and certain human engineering factors associated with point of care use of the TRS. We anticipate the data we collect in this study will form the basis of later medical device studies.

Primary Outcome

We will equip our portable Raman instrument with a non contact probe (PhAT probe, Kaiser Optical Systems). The probe will be placed \~ 10 inches from the wound and it will not be in contact with the wound. Depending on the size of the wound, the laser spot size on the wound bed will be 6-7.5 mm. The Raman spectra are derived from the laser light reflected back into the probe and captured by a charge coupled device (CCD) in the spectroscope. Computer software algorithms are used to deconvolute th

Interventions

  • DEVICE TRS

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2014-09
Est. Completion 2014-11
Phase NA
University of Michigan

1,327 total trials

Why NCT02202668 stopped before completion

NCT02202668 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).

The record links to 0 conditions, and to 1 intervention - of which TRS is the first listed.

NCT02202668 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02202668 about?

NCT02202668 is a clinical study titled "Transcutaneous Raman Spectroscope (TRS) Analyses of Diabetic Foot Ulcers". The primary translational research objective of the study is to demonstrate feasibility of using the Transcutaneous Raman Spectroscopy technology in a point-of-care environment. This study represents an initial evaluation of the device in a small cohort of human patients with diabetic foot ulcers. W...

What is the current status of trial NCT02202668?

This trial is currently terminated. It is a NA study. The enrollment target is 5 participants. The study started on 2014-09. Estimated completion is 2014-11.

What interventions are being tested in trial NCT02202668?

The interventions under investigation include: TRS (DEVICE).

Who is sponsoring clinical trial NCT02202668?

This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02202668's enrollment target sits among peer trials

5 1988th of 2000 higher than 5 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 NCT02202668, the US trial registry maintained by the National Library of Medicine. NCT02202668 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.