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

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.

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Key information

Conditions

Open Cracked Heel in Diabetic Patients With Polyneuropathy Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Glucose Metabolism Disorders Leg Ulcer Metabolic Diseases Nervous System Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Peripheral Nervous System Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brussels, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Tested product : V0111 cream

Device

Application twice a day during 28 days

PLACEBO

Device

Application twice a day during 28 days

Primary outcomes

Complete healing of target fissure on the heel

Time frame: Day 28

Comparison of the two treatment groups (verum versus placebo)

Sponsors and collaborators

Lead sponsor

Pierre Fabre Medicament

Industry

Registry information

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Jan 24, 2014
Registry last updated: Apr 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed