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

Primary Purpose

Open Cracked Heel in Diabetic Patients With Polyneuropathy

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Tested product : V0111 cream
Placebo
Sponsored by
Pierre Fabre Medicament
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Open Cracked Heel in Diabetic Patients With Polyneuropathy focused on measuring Diabetic Neuropathies, Diabetes Mellitus, Diabetic Foot, Diabetes Complications

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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,

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

V0111

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Complete healing of target fissure on the heel
Comparison of the two treatment groups (verum versus placebo)

Secondary Outcome Measures

Full Information

First Posted
January 20, 2014
Last Updated
April 24, 2015
Sponsor
Pierre Fabre Medicament
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1. Study Identification

Unique Protocol Identification Number
NCT02045199
Brief Title
Efficacy and Safety of V0111 Cream on Open Cracked Heel in Diabetic Patients With Polyneuropathy.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pierre Fabre Medicament

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Cracked Heel in Diabetic Patients With Polyneuropathy
Keywords
Diabetic Neuropathies, Diabetes Mellitus, Diabetic Foot, Diabetes Complications

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
193 (Actual)

8. Arms, Groups, and Interventions

Arm Title
V0111
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
Tested product : V0111 cream
Intervention Description
Application twice a day during 28 days
Intervention Type
Device
Intervention Name(s)
Placebo
Intervention Description
Application twice a day during 28 days
Primary Outcome Measure Information:
Title
Complete healing of target fissure on the heel
Description
Comparison of the two treatment groups (verum versus placebo)
Time Frame
Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Garrigue, MD
Organizational Affiliation
Pierre Fabre Médicament
Official's Role
Study Director
Facility Information:
City
Bruxelles
Country
Belgium
City
Edegem
Country
Belgium
City
Liege
Country
Belgium
City
Angers
Country
France
City
Bron
Country
France
City
La Rochelle
Country
France
City
Laval
Country
France
City
Mantes la Jolie
Country
France
City
Muret
Country
France
City
Nanterre
Country
France
City
Nice
Country
France
City
Nieuls sur Mer
Country
France
City
Paris
Country
France
City
Pessac
Country
France
City
Pringy
Country
France
City
Rillieux
Country
France
City
Saint Orens de Gameville
Country
France
City
Seysses
Country
France
City
Suresnes
Country
France
City
Tierce
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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