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NCT00316537 · ClinicalTrials.gov registry record · Phase 1

Safety and Preliminary Efficacy Study of Nicotine Gel to Treat Diabetic Foot Ulcers

A Phase 1 study, sponsored by CoMentis.

Terminated
Registry status
Phase 1
Development phase
48
Enrollment target

NCT00316537: Clinical Trial Phase 1 study, sponsored by CoMentis.

NCT00316537 is a Phase 1 study that was terminated before completion, run by CoMentis. The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT00316537, a Phase 1 study, was terminated before completion, sponsored by CoMentis.

TERMINATED
Registry status
Phase 1
Development phase
48 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the safety and preliminary efficacy of low dose nicotine gel in patients with chronic diabetic ulcers

Interventions

  • DRUG ATG002 (study drug)

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2006-10
Est. Completion 2007-07
Phase Phase 1
CoMentis

6 total trials

Why NCT00316537 stopped before completion

NCT00316537 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).

The record links to 0 conditions, and to 1 intervention - of which ATG002 (study drug) is the first listed.

NCT00316537 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00316537 about?

NCT00316537 is a clinical study titled "Safety and Preliminary Efficacy Study of Nicotine Gel to Treat Diabetic Foot Ulcers". The purpose of this study is to evaluate the safety and preliminary efficacy of low dose nicotine gel in patients with chronic diabetic ulcers

What is the current status of trial NCT00316537?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2006-10. Estimated completion is 2007-07.

What interventions are being tested in trial NCT00316537?

The interventions under investigation include: ATG002 (study drug) (DRUG).

Who is sponsoring clinical trial NCT00316537?

This trial is sponsored by CoMentis, which has 6 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00316537's enrollment target sits among peer trials

48 1025th of 2000 higher than 948 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT00316537, the US trial registry maintained by the National Library of Medicine. NCT00316537 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.