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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02385903

Acronym

Flammacérium

Enrollment

Registered

2015-03-11

Start date

2009-09-30

Completion date

2015-10-31

Last updated

2016-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Wound of the Lower Limb, Necrotic Arterial Wounds

Keywords

Flammacerium, Ischemic wound, Lower limb, Arteriopathy, Amputation, Dressing

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.

Interventions

OTHERFlammacerium

OTHERStandard dressing procedure

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Amputation rate	6 months	Level of amputation

Secondary

Measure	Time frame
Infection rate	6 months
Wound size	6 months
Pain during dressing (VAS)	6 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026