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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pierre Fabre Medicament
ClinicalTrials.gov Identifier:
NCT02045199
First received: January 20, 2014
Last updated: April 24, 2015
Last verified: April 2015
  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)


Enrollment: 193
Study Start Date: February 2014
Study Completion Date: March 2015
Primary Completion Date: March 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

Locations
Belgium
Bruxelles, Belgium
Edegem, Belgium
Liege, Belgium
France
Angers, France
Bron, France
La Rochelle, France
Laval, France
Mantes la Jolie, France
Muret, France
Nanterre, France
Nice, France
Nieuls sur Mer, France
Paris, France
Pessac, France
Pringy, France
Rillieux, France
Saint Orens de Gameville, France
Seysses, France
Suresnes, France
Tierce, France
Sponsors and Collaborators
Pierre Fabre Medicament
Investigators
Study Director: Eric Garrigue, MD Pierre Fabre Médicament
  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: April 24, 2015
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
Nervous System Diseases
Neuromuscular Diseases
Peripheral Nervous System Diseases

ClinicalTrials.gov processed this record on May 27, 2015