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

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.
ClinicalTrials.gov Identifier: NCT02045199
Recruitment Status : Completed
First Posted : January 24, 2014
Last Update Posted : April 27, 2015
Information provided by (Responsible Party):

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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 193 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Study Start Date : February 2014
Primary Completion Date : March 2015
Study Completion Date : March 2015
Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Complete healing of target fissure on the heel [ Time Frame: Day 28 ]
    Comparison of the two treatment groups (verum versus placebo)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Bruxelles, Belgium
Edegem, Belgium
Liege, Belgium
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
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 Posted: January 24, 2014    Key Record Dates
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:
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases