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

NCT02385903 | Terminated Phase 2 DMC

• 1 other identifier: 8546
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Wound of the Lower Limb; Necrotic Arterial Wounds

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Amputation rate

  Level of amputation

  6 months

Secondary Outcomes (3)

• Infection rate

  6 months

• Wound size

  6 months

• Pain during dressing (VAS)

  6 months

Study Arms (2)

Standard dressing procedure

OTHER

One arm receive standard dressing procedure according to the wound

Other: Standard dressing procedure

Flammacerium

ACTIVE COMPARATOR

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

Interventions

Flammacerium OTHER

Flammacerium

Standard dressing procedure OTHER

Standard dressing procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Sulphonamide hypersensibility
• Propyleneglycols hypersensibility
• Enzyme glucose deshydrogenase deficiencies
• Others studies participation
• Tutorship or curatoship

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Rangueil Hospital: collaborator
• University Hospital, Caen: collaborator
• Beziers Hospital: collaborator

Study Sites (1)

Wound healing Department

Montpellier, 34295, France

Location

MeSH Terms

Interventions

cerous nitrate, sulfadiazine silver drug combination

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2015
• First Posted: March 11, 2015
• Study Start: September 1, 2009
• Primary Completion: April 1, 2015
• Study Completion: October 1, 2015
• Last Updated: December 1, 2016

Record last verified: 2016-11

Locations

FR (1)