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

URGO Group

Status: Unknown

Conditions: Diabetic Foot Ulcer

Treatments: Device: Dressing with LU3103209 - Dose 1; Device: Dressing without LU3103209; Device: Dressing with LU3103209 - Dose 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT03110796

FI-16-03-310 3209

Details and patient eligibility

About

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.

Full 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).

Enrollment: 210 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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210 participants in 3 patient groups, including a placebo group

LU3103209 Dose 1

Experimental group

Description:

Dressing with LU3103209 Dose 1

Treatment:

Device: Dressing with LU3103209 - Dose 1

LU3103209 Dose 2

Experimental group

Description:

Dressing with LU3103209 Dose 2

Treatment:

Device: Dressing with LU3103209 - Dose 2

No LU3103209

Placebo Comparator group

Description:

Dressing without LU3103209

Treatment:

Device: Dressing without LU3103209