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

November 30, 2016 updated by: University Hospital, Montpellier
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • Wound healing Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Standard dressing procedure
One arm receive standard dressing procedure according to the wound
Other: Standard dressing procedure
Active Comparator: 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.
Other: Flammacerium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amputation rate
Time Frame: 6 months
Level of amputation
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Infection rate
Time Frame: 6 months
6 months
Wound size
Time Frame: 6 months
6 months
Pain during dressing (VAS)
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Collaborators

University Hospital, Caen
Beziers Hospital
Rangueil Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

February 24, 2015

First Submitted That Met QC Criteria

March 10, 2015

First Posted (Estimate)

March 11, 2015

Study Record Updates

Last Update Posted (Estimate)

December 1, 2016

Last Update Submitted That Met QC Criteria

November 30, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8546

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ischemic Wound of the Lower Limb

Clinical Trials on Standard dressing procedure

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Albania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe