Evaluation of the Cryopreserved Amniotic Membranes in the... | NCT00820274

Studies
Evaluation of the Cryopreserved Amniotic Membranes in the Care of Resistant Vascular Ulcers

NCT00820274

Sponsor

University Hospital, Limoges

Status

Terminated

Last Update Posted

Sep 1, 2015Estimated

Enrollment

10Actual

Phase

Phase 2

Conditions

Resistant Vascular Ulcers

Interventions

amniotic membranes

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

clinical trial have encountered difficulties enrolling a sufficient number of patients

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Dec 2013Actual

Completion Date

Jun 2016Estimated

First Submitted Date

Jan 9, 2009

First Submission Date that Met QC Criteria

Jan 9, 2009

First Posted Date

Jan 12, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 31, 2015

Last Update Posted Date

Sep 1, 2015Estimated

Name	Class
Etablissement Français du Sang	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To evaluate tolerance and efficiency of cryopreserved amniotic membranes in local treatment of resistant vascular ulcers.

To evaluate complete cicatrisation, efficiency on pain, prevention of infection, improvement of quality of life.

To evaluate rate of amputations and recurrence at one year after complete cicatrisation

Detailed Description

Treatment of patients suffering from vascular ulcers or amputation's wound from at least 6 months after or without possibility for surgical treatment. A cryopreserved amniotic membrane, obtained after caesarean from consenting women without any disease, is applied on the ulcer after serological checking and changed once a week.

Main criterias:

Tolerance will be evaluated on clinical criterias. Efficiency will be evaluated by measuring reduction of ulcer's area (reduction of at least 50 % at 6 months).

Secondary criterias:

Reduction of pain will be evaluated by analogic visual scale and evaluation of analgesic consumption.

Evaluation of infections, amputations, complete healing, improvement of quality of life by SF36 questionnaire and recurrence at one year for patients with complete healing.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
amniotic membranes	Experimental		Procedure: amniotic membranes

Interventions

Name	Type	Description	Arm Group Labels	Other Names
amniotic membranes	Procedure	The amniotic membrane is taken with a sterile crowbar then applied side foetal face against the ulcer and displayed in a homogeneous way	amniotic membranes

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measure of the diameter of the ulcer		Every week

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Obtained informed consent
Leg or foot arterial or mixed ulcer older than at least 3 months

Exclusion Criteria:

No obtained informed consent
Possibility for surgical treatment (revascularisation)
Age less than 18
Pregnancy
Indication for major amputation (below /above the knee)
Venous ulcer
Ulcer with infection and / or necrosis
Mycotic ulcer

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Francis Pesteil, MD	CHU Limoges	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Médecine Interne et Pathologie Vasculaire		Bordeaux		33075	France
Service de Chirurgie Vasculaire et Viscérale