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

Ischemic Wound of the Lower Limb Clinical Trial

— Flammacérium  

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02385903
• Other study ID #: 8546
• Status: Terminated
• Phase: Phase 2
• First received: February 24, 2015
• Last updated: November 30, 2016
• Start date: September 2009
• Est. completion date: October 2015

Study information

• Verified date: November 2016
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 55
• Est. completion date: October 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ischemic Wound of the Lower Limb
• Necrosis
• Necrotic Arterial Wounds
• Wounds and Injuries

Intervention

Other:
• Flammacerium

• Standard dressing procedure

Locations

Country	Name	City	State
France	Wound healing Department	Montpellier

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Beziers Hospital, Rangueil Hospital, University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amputation rate	Level of amputation	6 months	Yes
Secondary	Infection rate		6 months	Yes
Secondary	Wound size		6 months	Yes
Secondary	Pain during dressing (VAS)		6 months	Yes