Efficacy and Safety of V0111 Cream on Open Cracked Heel in Diabetic Patients With Polyneuropathy.

NCT ID: NCT02045199

Last Updated: 2015-04-27

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

COMPLETED

Clinical Phase

NA

Total Enrollment

193 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-03-31

Brief Summary

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The purpose of this study is to evaluate the efficacy and the safety of the cream V0111 in the treatment of fissure(s) situated on the heels in diabetic patients with polyneuropathy.

Detailed Description

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Conditions

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Open Cracked Heel in Diabetic Patients With Polyneuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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V0111

Group Type EXPERIMENTAL

Tested product : V0111 cream

Intervention Type DEVICE

Application twice a day during 28 days

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DEVICE

Application twice a day during 28 days

Interventions

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Tested product : V0111 cream

Application twice a day during 28 days

Intervention Type DEVICE

Placebo

Application twice a day during 28 days

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Diabetes mellitus with neuropathy,
* Cracked open heel with at least one fissure Grade 2,

Exclusion Criteria

* Open wound, skin infection, haemorrhagic crack on feet,
* Major static disorder ,
* Ulceration and history of ulceration,
* Active haemorrhagic crack,
* Hyperkeratotic disease
* Diabetic arteriopathy,
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pierre Fabre Medicament

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric Garrigue, MD

Role: STUDY_DIRECTOR

Pierre Fabre Médicament

Locations

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Brussels, , Belgium

Site Status

Edegem, , Belgium

Site Status

Liège, , Belgium

Site Status

Angers, , France

Site Status

Bron, , France

Site Status

La Rochelle, , France

Site Status

Laval, , France

Site Status

Mantes-la-Jolie, , France

Site Status

Muret, , France

Site Status

Nanterre, , France

Site Status

Nice, , France

Site Status

Nieuls Sur Mer, , France

Site Status

Paris, , France

Site Status

Pessac, , France

Site Status

Pringy, , France

Site Status

Rillieux Village, , France

Site Status

Saint-Orens-de-Gameville, , France

Site Status

Seysses, , France

Site Status

Suresnes, , France

Site Status

Tiercé, , France

Site Status

Countries

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Belgium France

Other Identifiers

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2013-A01394-41

Identifier Type: OTHER

Identifier Source: secondary_id

V00111 CR 0 02

Identifier Type: -

Identifier Source: org_study_id

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