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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Laboratoires URGO
Sponsor:
Information provided by (Responsible Party):
Laboratoires URGO
ClinicalTrials.gov Identifier:
NCT01717183
First received: October 26, 2012
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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 Intervention
Diabetic Foot Ulcer(s)
Device: Urgo 310 3113
Device: Placebo URGO 310 3113 dressing

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Laboratoires URGO:

Primary Outcome Measures:
  • Percentage of complete wound closure

Secondary Outcome Measures:
  • Time to complete wound closure
  • Change in wound surface area

Study Start Date: April 2013
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01717183

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

Locations
France
Recruiting
Toulouse, France
Contact: Jacques MARTINI, MD         
Sponsors and Collaborators
Laboratoires URGO
  More Information

No publications provided

Responsible Party: Laboratoires URGO
ClinicalTrials.gov Identifier: NCT01717183     History of Changes
Other Study ID Numbers: FI-12-05-310 3113
Study First Received: October 26, 2012
Last Updated: April 10, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Ethics Commission
Italy: Ethics Committee
United Kingdom: Research Ethics Committee
United Kingdom: National Health Service

Keywords provided by Laboratoires URGO:
Patient

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

ClinicalTrials.gov processed this record on July 22, 2014