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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01717183
Recruitment Status : Unknown
Verified April 2014 by Laboratoires URGO.
Recruitment status was:  Recruiting
First Posted : October 30, 2012
Last Update Posted : April 11, 2014
Information provided by (Responsible Party):
Laboratoires URGO

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer(s) Device: Urgo 310 3113 Device: Placebo URGO 310 3113 dressing Not Applicable

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. Percentage of complete wound closure

Secondary Outcome Measures :
  1. Time to complete wound closure
  2. Change in wound surface area

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01717183

Contact: Jacques MARTINI, MD 00 33 5 61 32 32 89

Toulouse, France
Contact: Jacques MARTINI, MD         
Sponsors and Collaborators
Laboratoires URGO

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Laboratoires URGO Identifier: NCT01717183     History of Changes
Other Study ID Numbers: FI-12-05-310 3113
First Posted: October 30, 2012    Key Record Dates
Last Update Posted: April 11, 2014
Last Verified: April 2014

Keywords provided by Laboratoires URGO:

Additional relevant MeSH terms:
Diabetic Foot
Foot Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases