MedDataX Logo

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

NCT ID: NCT02385903

Last Updated: 2016-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2015-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ischemic Wound of the Lower Limb Necrotic Arterial Wounds

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Flammacerium Ischemic wound Lower limb Arteriopathy Amputation Dressing

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard dressing procedure

One arm receive standard dressing procedure according to the wound

Group Type OTHER

Standard dressing procedure

Intervention Type OTHER

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.

Group Type ACTIVE_COMPARATOR

Flammacerium

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Flammacerium

Intervention Type OTHER

Standard dressing procedure

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Rangueil Hospital

OTHER

Sponsor Role collaborator

University Hospital, Caen

OTHER

Sponsor Role collaborator

Beziers Hospital

OTHER

Sponsor Role collaborator

University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Wound healing Department

Montpellier, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

8546

Identifier Type: -

Identifier Source: org_study_id