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NCT01849965 · ClinicalTrials.gov registry record · Phase 3

Phase 3 Study Evaluating Efficacy and Safety of DSC127 Compared With Vehicle and With Standard-of-care in Diabetic Foot Ulcers

A Phase 3 study, sponsored by Integra LifeSciences Corporation.

Terminated
Registry status
Phase 3
Development phase
396
Enrollment target

NCT01849965 is a Phase 3 study that was terminated before completion, run by Integra LifeSciences Corporation. The registered enrollment target is 396 participants.

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The verdict

NCT01849965, a Phase 3 study, was terminated before completion, sponsored by Integra LifeSciences Corporation.

TERMINATED
Registry status
Phase 3
Development phase
396 participants
Enrollment target

Study Summary

To determine if aclerastide (DSC127) is effective in increasing incidence of complete wound closure up to 10 weeks confirmed 2 weeks later, compared with vehicle (gel without active ingredient) and compared with a standard-of-care gel, in subjects with diabetes mellitus (DM) who have chronic Wagner Grade 1 or 2 diabetic foot ulcers, 0.75 - 6cm2 in size.

Interventions

  • DRUG DSC127
  • DRUG placebo vehicle gel
  • DRUG Standard of Care gel, Aquasite

Trial Details

FieldValue
Enrollment Target 396 participants
Start Date 2013-04
Est. Completion 2015-12
Phase Phase 3

Sponsor

Integra LifeSciences Corporation

60 total trials

What the Registry Record Tells You About NCT01849965

The ClinicalTrials.gov registry entry for NCT01849965 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 396 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Integra LifeSciences Corporation, which has 60 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which DSC127 is the first listed.

NCT01849965 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01849965 about?

NCT01849965 is a clinical study titled "Phase 3 Study Evaluating Efficacy and Safety of DSC127 Compared With Vehicle and With Standard-of-care in Diabetic Foot Ulcers". To determine if aclerastide (DSC127) is effective in increasing incidence of complete wound closure up to 10 weeks confirmed 2 weeks later, compared with vehicle (gel without active ingredient) and compared with a standard-of-care gel, in subjects with diabetes mellitus (DM) who have chronic Wagner ...

What is the current status of trial NCT01849965?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 396 participants. The study started on 2013-04. Estimated completion is 2015-12.

What interventions are being tested in trial NCT01849965?

The interventions under investigation include: DSC127 (DRUG), placebo vehicle gel (DRUG), Standard of Care gel, Aquasite (DRUG).

Who is sponsoring clinical trial NCT01849965?

This trial is sponsored by Integra LifeSciences Corporation, which has 60 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.