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A RCT to Compare the Effects of Two Wound Products on Biofilm Disruption in DFUs

NCT02181621 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2024-02-29

Study results available
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Summary

This study is a prospective comparative study to determine if an Iodine Gel (Iodosorb◊) is better than standard dressing (Solosite◊ gel) in disruption of biofilm (small microorganism bacteria similar to plaque on teeth) on the wound bed diabetic foot ulcers.

◊ Trademark of Smith \& Nephew

Conditions

  • Diabetic Foot Ulcer

Interventions

DEVICE

Iodosorb

Cadexomer iodine gel

DEVICE

Solosite gel

Hydrogel

Sponsors & Collaborators

  • Smith & Nephew, Inc.

    lead INDUSTRY

Principal Investigators

  • John Lantis, BSc, MD · St Lukes Roosevelt Hospital Center

  • Matthew Christensen · Smith & Nephew, Inc. - SVP Global Clinical & Medical Affairs

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02181621 on ClinicalTrials.gov