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

Pierre Fabre

Status: Completed

Conditions: Open Cracked Heel in Diabetic Patients With Polyneuropathy

Treatments: Device: Tested product : V0111 cream; Device: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02045199

2013-A01394-41 (Other Identifier)

V00111 CR 0 02

Details and patient eligibility

About

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.

Enrollment: 193 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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,

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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193 participants in 2 patient groups, including a placebo group

V0111

Experimental group

Treatment:

Device: Tested product : V0111 cream

Placebo

Placebo Comparator group

Treatment:

Device: Placebo