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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Pierre Fabre Medicament
Sponsor:
Information provided by (Responsible Party):
Pierre Fabre Medicament
ClinicalTrials.gov Identifier:
NCT02045199
First received: January 20, 2014
Last updated: June 12, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Open Cracked Heel in Diabetic Patients With Polyneuropathy
Device: Tested product : V0111 cream
Device: Placebo

Study Type: Interventional
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

Further study details as provided by Pierre Fabre Medicament:

Primary Outcome Measures:
  • Complete healing of target fissure on the heel [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
    Comparison of the two treatment groups (verum versus placebo)


Estimated Enrollment: 162
Study Start Date: February 2014
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: V0111 Device: Tested product : V0111 cream
Application twice a day during 28 days
Placebo Comparator: Placebo Device: Placebo
Application twice a day during 28 days

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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,
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02045199

Contacts
Contact: Pierre Fabre Médicament contact_essais_cliniques@pierre-fabre.com

Locations
Belgium
Not yet recruiting
Bruxelles, Belgium
Not yet recruiting
Edegem, Belgium
Not yet recruiting
Liege, Belgium
France
Recruiting
Angers, France
Recruiting
Bron, France
Not yet recruiting
La Rochelle, France
Not yet recruiting
Laval, France
Recruiting
Muret, France
Recruiting
Nice, France
Not yet recruiting
Nieuls sur Mer, France
Recruiting
Paris, France
Recruiting
Pessac, France
Recruiting
Pringy, France
Recruiting
Saint Orens de Gameville, France
Recruiting
Seysses, France
Recruiting
Tierce, France
Sponsors and Collaborators
Pierre Fabre Medicament
  More Information

No publications provided

Responsible Party: Pierre Fabre Medicament
ClinicalTrials.gov Identifier: NCT02045199     History of Changes
Other Study ID Numbers: V00111 CR 0 02, 2013-A01394-41
Study First Received: January 20, 2014
Last Updated: June 12, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Committee for the Protection of Personnes
Belgium: Ethics Committee

Keywords provided by Pierre Fabre Medicament:
Diabetic Neuropathies
Diabetes Mellitus
Diabetic Foot
Diabetes Complications

Additional relevant MeSH terms:
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 22, 2014