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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02045199
First Posted: January 24, 2014
Last Update Posted: April 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pierre Fabre Medicament
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Pierre Fabre Medicament
ClinicalTrials.gov Identifier: NCT02045199     History of Changes
Other Study ID Numbers: V00111 CR 0 02
2013-A01394-41 ( Other Identifier: ID RCB Number )
First Submitted: January 20, 2014
First Posted: January 24, 2014
Last Update Posted: April 27, 2015
Last Verified: April 2015

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