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

Diabetic Foot Ulcer Clinical Trial

— DISCOVERY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03110796
• Other study ID #: FI-16-03-310 3209
• Status: Recruiting
• Phase: N/A
• Start date: July 31, 2017
• Est. completion date: January 2020

Study information

• Verified date: January 2019
• Source: Laboratoires URGO
• Contact: Anne Sauvadet, PhD
• Phone: +33380442884
• Email: a.sauvadet[@]fr.urgo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

Device:
• Dressing with LU3103209 - Dose 1
Dressing with LU3103209 - Dose 1
• Dressing with LU3103209 - Dose 2
Dressing with LU3103209 - Dose 2
• Dressing without LU3103209
Dressing without LU3103209

Locations

Country	Name	City	State
Czechia	Pr JIRKOVSKA	Praha
France	Pr PETIT	Dijon
Italy	Pr PIAGGESI	Pisa
Poland	Dr KORZON	Gdansk
Spain	Pr LAZARO	Madrid
United Kingdom	Pr EDMONDS	London

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoires URGO

Countries where clinical trial is conducted

Czechia,  France,  Italy,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% of Wound Area Regression (WAR), as a measure of efficacy	Efficacy of dressings with LU3103209 versus dressing without LU3103209	12 weeks