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

Phase 2

Terminated

• Conditions: Ischemic Wound of the Lower Limb; Necrotic Arterial Wounds
• Interventions: Other: Standard dressing procedure; Other: Flammacerium

• Registration Number: NCT02385903
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2015-02-24
• Study First Submitted QC: 2015-03-10
• Study First Posted: 2015-03-11
• Primary Completion: 2015-04
• Study Completion: 2015-10
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-30
• Last Update Posted: 2016-12-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard dressing procedure	Standard dressing procedure	One arm receive standard dressing procedure according to the wound
Flammacerium	Flammacerium	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.

Primary Outcome Measures

Name	Time	Method
Amputation rate	6 months	Level of amputation

Secondary Outcome Measures

Name	Time	Method
Infection rate	6 months
Wound size	6 months
Pain during dressing (VAS)	6 months

Trial Locations

Locations (1)

Wound healing Department; 🇫🇷 Montpellier, France