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

Open Cracked Heel in Diabetic Patients With Polyneuropathy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02045199
• Other study ID #: V00111 CR 0 02
• Secondary ID: 2013-A01394-41
• Status: Completed
• Phase: N/A
• First received: January 20, 2014
• Last updated: April 24, 2015
• Start date: February 2014
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: Pierre Fabre Medicament
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of PersonnesBelgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 193
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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,

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Open Cracked Heel in Diabetic Patients With Polyneuropathy
• Polyneuropathies

Intervention

Device:
• Tested product : V0111 cream
Application twice a day during 28 days
• Placebo
Application twice a day during 28 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pierre Fabre Medicament

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete healing of target fissure on the heel	Comparison of the two treatment groups (verum versus placebo)	Day 28	No