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

University Hospital Center (CHU)

Status and phase: Terminated; Phase 2

Conditions: Necrotic Arterial Wounds; Ischemic Wound of the Lower Limb

Treatments: Other: Standard dressing procedure; Other: Flammacerium

Study type: Interventional

Funder types: Other

Identifiers

NCT02385903

8546

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 2 patient groups

Standard dressing procedure

Other group

Description:

One arm receive standard dressing procedure according to the wound

Treatment:

Other: Standard dressing procedure

Flammacerium

Active Comparator group

Description:

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.

Treatment:

Other: Flammacerium