Assessment of the Efficacy and Safety of a New Wound Dressing in the Local Treatment of Diabetic Foot Ulcers

April 10, 2014 updated by: Laboratoires URGO

Assessment of the Efficacy and Safety of a New Wound Dressing in the Local Treatment of Diabetic Foot Ulcers: a Prospective, Randomised, Controlled, Double-blind, European Multicentre Clinical Trial

The main purpose of this trial is to demonstrate that the new dressing is more effective than the current dressing in the local treatment of chronic foot ulcers in diabetic patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France
        • Recruiting
        • Contact:
          • Jacques MARTINI, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female over 18 years old who has provided his/her written informed consent
  • Patient covered by the French national insurance system
  • Patient with Type 1 or Type 2 diabetes mellitus with glycated hemoglobi(HbA1c) levels ≤ 10% (assayed in the previous 3 months. If not available, this assay must be performed during the run-in period)
  • Inpatient or outpatient who can be monitored by the same investigating team throughout the duration of the study
  • Patient who agrees to wear the prescribed off-loading system every day, associated with the test dressing
  • DFU with adequate arterial blood supply in the target limb DFU grade I-C or II-C as defined by the University of Texas Diabetic Wound Classification
  • Neuropathy confirmed by loss of protective sensation to monofilament test (Semmes-Weinstein 5.07 monofilament)
  • DFU located on the toe or on the lateral, dorsal or plantar side of the foot
  • Target DFU surface area between 1 cm² and 30 cm², following debridement DFU duration between 1 and 24 months
  • No local clinical infection (as defined by IDSA/IWGDF criteria) for any wound (target DFU or not) on lower limbs
  • DFU adequately debrided

Exclusion Criteria:

  • Pregnant or breast-feeding woman or woman of childbearing potential not using effective means of contraception
  • Patient who took part in another clinical trial in the previous month or who is to take part in another clinical trial in the 20 weeks following inclusion
  • Patient with any known intolerance or allergy or reported adverse reaction to one of the components of the trial dressings
  • Patient who has undergone surgery or surgical revascularization (vascular reconstruction or angioplasty) in the previous 2 months
  • Patient who has presented an acute ischemic event (Acute Myocardial Infarction (AMI) or stroke) in the 3 months before inclusion
  • Patient with Severe kidney failure, defined as requirement for dialysis
  • Patient with a systemic infection not controlled by suitable antibiotic treatment
  • Patient with known osteomyelitis
  • Patient with leg ulcer(s), regardless of limb
  • Patient with wounds other than the target DFU located on the heel or on the interdigital part of the foot
  • Patient with an active neoplastic condition, treated by radiotherapy, chemotherapy, hormone therapy or immunosuppressant agents
  • Patient treated for a chronic disease requiring high doses of systemic corticosteroids (≥ 40 mg.d-1 of prednisolone or equivalent)
  • Patient with a severe illness that might lead to premature withdrawal from the trial
  • DFU for which surgery or surgical revascularization is planned at any time during the study
  • Deep DFU defined as stage III or IV (University of Texas Diabetic Wound Classification)
  • DFU clinically infected as defined by IDSA/IWGDF criteria
  • DFU with more than 20% of its surface area covered by black necrotic tissue following debridement
  • DFU located on an amputation stump
  • DFU with neoplastic component

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: URGO 310 3113 dressing - new
flexible, conformable, non-adhesive and non-occlusive lipido-colloid matrix that does not adhere to the wound.
Device: Urgo 310 3113
URGO 310 3113 dressing may be changed every 2 to 4 days, and left in place for up to 7 days, depending on the level of exudate and the wound condition
PLACEBO_COMPARATOR: URGO 310 3113 dressing
flexible, conformable, non-adhesive and non-occlusive lipido-colloid matrix that does not adhere to the wound.
Device: Placebo URGO 310 3113 dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Percentage of complete wound closure

Secondary Outcome Measures

Outcome Measure
Time to complete wound closure
Change in wound surface area

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratoires URGO

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Study Registration Dates

First Submitted

October 26, 2012

First Submitted That Met QC Criteria

October 29, 2012

First Posted (ESTIMATE)

October 30, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

April 11, 2014

Last Update Submitted That Met QC Criteria

April 10, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FI-12-05-310 3113

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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