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Prontosan Versus Saline in the Cleansing of Chronic Leg Ulcers in Diabetic Patients

NCT01554644 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2013-07-16

No results posted yet for this study

Summary

This is a randomized controlled double blinded study involving two (2) investigational sites in the United States. All subjects (n=40) will receive either Prontosan Wound Irrigation Solution and Gel treatment or standard of care treatment (0.9% saline) and placebo gel. This is a 12-week study.

Conditions

  • Diabetic Complications

Interventions

DEVICE

Prontosan

Prontosan(TM) Wound Irrigation Solution (PHMB 0.1%, Betaine 0.1%) and Prontosan(TM) Wound Gel (PHMB 0.1%, Betaine 0.1%). Dressings will be changed and the treatment procedure will be repeated daily with 30ml/40 ml wound solution and 30 ml wound gel for a period of 12 weeks.

DEVICE

Saline

Saline Wound Irrigation Solution and inert Wound Gel. Dressings will be changed and the treatment procedure will be repeated daily with 30ml/40 ml wound solution and 30 ml wound gel for a period of 12 weeks.

Sponsors & Collaborators

  • B. Braun Medical Inc.

    lead INDUSTRY

Principal Investigators

  • William Ennis, DO · University of Illinois Chicago

  • Gerit Mulder, DPM · University of California, San Diego

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2012-09-30
Completion
2012-10-31

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 NCT01554644 on ClinicalTrials.gov