Randomized Controlled Trial on the Use of Flammacerium in Necrotic Arterial Wounds of the Lower Limb Versus Standard Treatment

Study Overview
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Brief Summary
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Ischemia of an area may lead to a necrotic wound. In lower limb, it especially happens in diabetic or artheriopatic patients. It can lead to an amputation need. Revascularization procedure cannot be provide in all cases. Flammacerium, by a crust training and its anti-inflammatory effect, could stabilize necrosis extension, avoid bacterial contamination and then improve some incapacitating symptoms like odor or pain. This product may allow to delay amputation ruling for patients on who this procedure is unsafe. During 6 months, the investigators evaluate Flammacerium against standard dressing procedure in necrotic wound of the lower limb in patients where no revascularization can be provide. The investigators observed its effect on amputation need, symptoms as pain, infection, wound aspect evolution, wound size decrease.

Conditions
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Ischemic Wound of the Lower Limb, Necrotic Arterial Wounds

Intervention / Treatment
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* Other: Flammacerium
* Other: Standard dressing procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ischemic wound of the lower limb Minimum 50% necrosis Arteriopathy with ABI<0.7 or >1.3 with radiographic examinations No revascularisation procedure possible for any reasons No urgent amputation need Amputation considered in a short term Non life-threatened patients Exclusion Criteria: Sulphonamide hypersensibility Propyleneglycols hypersensibility Enzyme glucose deshydrogenase deficiencies Others studies participation Tutorship or curatoship

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard dressing procedure<br>One arm receive standard dressing procedure according to the wound | Other: Standard dressing procedure<br> <br> |
| Active Comparator: Flammacerium<br>Necrosis covering with Flammacerium 3 mm thick each day during one week then one day on two. On each dressing, remove excess and add flammacerium. Not to remove crust forming until eliminating furrow appears. Cover Flammacerium by compress. | Other: Flammacerium<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amputation rate | Level of amputation | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection rate |  | 6 months | 
| Wound size |  | 6 months | 
| Pain during dressing (VAS) |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Flammacerium, Ischemic wound, Lower limb, Arteriopathy, Amputation, Dressing