Assessment of the Efficacy and Safety of a New Medical Device in the Local Treatment of Diabetic Foot Ulcers (DISCOVERY)

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

Evaluation of the efficacy and safety of a device with LU3103209 compound versus the same device, free of LU3103209 compound, in the local management of DFUs.

Study Overview

• Status: Unknown
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Device: Dressing with LU3103209 - Dose 1; Device: Dressing with LU3103209 - Dose 2; Device: Dressing without LU3103209

Detailed Description

A European prospective, randomized, double-blind, multicentre, clinical trial, conducted in three parallel groups, to evaluate the efficacy and safety of a device with LU3103209 compound versus the same device, free of LU3103209 compound, in the local management of diabetic foot ulcers (DFUs).

• Study Type: Interventional
• Enrollment (Anticipated): 210
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Praha, Czechia
    • Recruiting
    • Pr JIRKOVSKA
• France
  • Dijon, France
    • Recruiting
    • Pr PETIT
• Italy
  • Pisa, Italy
    • Recruiting
    • Pr PIAGGESI
• Poland
  • Gdańsk, Poland
    • Recruiting
    • Dr KORZON
• Spain
  • Madrid, Spain
    • Recruiting
    • Pr LAZARO
• United Kingdom
  • London, United Kingdom
    • Recruiting
    • Pr EDMONDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female over 18 years old who has provided his/her written informed consent
2. Patient with Type 1 or Type 2 diabetes mellitus with glycated haemoglobin (HbA1c) level ≤ 10%
3. Inpatient or outpatient who can be monitored by the same investigating team throughout the entire study
4. Patient who agrees to wear an off-loading system during the trial
5. Diagnosis of peripheral neuropathy
6. Patient with an adequate arterial perfusion of the affected limb, confirmed by ABPI and Toe Blood Pressure assessment
7. DFU Grade 1-A or 2-A or 1-C or 2-C as defined by the University of Texas Diabetic Wound Classification System
8. Target DFU surface area between 1 cm² to 10 cm², after debridement
9. DFU present since less than 24 months

Exclusion Criteria:

A. Pregnant or breast-feeding woman or woman of childbearing potential not protected by an effective contraceptive method of birth control B. Patient who participated in another clinical trial in the previous month or who will take part in another clinical trial during the 12 weeks following the inclusion C. Patient with severe renal impairment D. Patient who has presented, during the 3 months before inclusion, an acute ischemic event (acute myocardial infarction or stroke) E. Patient with an active neoplastic condition, treated by radiotherapy, chemotherapy, hormone therapy or immunosuppressant F. Patient treated for a chronic disease requiring high doses of systemic corticosteroids on a daily basis (≥ 40 mg prednisolone) G. Patient with infection which is not controlled by a suitable antibiotic treatment H. Patient with any known allergy or reported adverse reaction to the trial device

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LU3103209 Dose 1; Dressing with LU3103209 Dose 1	Device: Dressing with LU3103209 - Dose 1; Dressing with LU3103209 - Dose 1
Experimental: LU3103209 Dose 2; Dressing with LU3103209 Dose 2	Device: Dressing with LU3103209 - Dose 2; Dressing with LU3103209 - Dose 2
Placebo Comparator: No LU3103209; Dressing without LU3103209	Device: Dressing without LU3103209; Dressing without LU3103209

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% of Wound Area Regression (WAR), as a measure of efficacy	Efficacy of dressings with LU3103209 versus dressing without LU3103209	12 weeks

Collaborators and Investigators

• Sponsor: Laboratoires URGO

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2017
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: March 30, 2017
• First Submitted That Met QC Criteria: April 11, 2017
• First Posted (Actual): April 12, 2017

Study Record Updates

• Last Update Posted (Actual): January 17, 2019
• Last Update Submitted That Met QC Criteria: January 16, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: FI-16-03-310 3209

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No