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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-31

Study Completion Date

2020-01-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Diabetic Foot Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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LU3103209 Dose 1

Dressing with LU3103209 Dose 1

Group Type EXPERIMENTAL

Dressing with LU3103209 - Dose 1

Intervention Type DEVICE

Dressing with LU3103209 - Dose 1

LU3103209 Dose 2

Dressing with LU3103209 Dose 2

Group Type EXPERIMENTAL

Dressing with LU3103209 - Dose 2

Intervention Type DEVICE

Dressing with LU3103209 - Dose 2

No LU3103209

Dressing without LU3103209

Group Type PLACEBO_COMPARATOR

Dressing without LU3103209

Intervention Type DEVICE

Dressing without LU3103209

Interventions

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Dressing with LU3103209 - Dose 1

Intervention Type DEVICE

Dressing with LU3103209 - Dose 2

Intervention Type DEVICE

Dressing without LU3103209

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No