Efficacy and Safety of V0111 Cream on Open Cracked Heel in Diabetic Patients With Polyneuropathy.
Not Applicable
Completed
- Conditions
- Open Cracked Heel in Diabetic Patients With Polyneuropathy
- Interventions
- Device: Placebo
- Registration Number
- NCT02045199
- Lead Sponsor
- Pierre Fabre Medicament
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 193
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,
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo -
- Primary Outcome Measures
Name Time Method Complete healing of target fissure on the heel Day 28 Comparison of the two treatment groups (verum versus placebo)
- Secondary Outcome Measures
Name Time Method