NCT00820274

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_2

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 12, 2009

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

September 1, 2015

Status Verified

December 1, 2013

Enrollment Period

4.9 years

First QC Date

January 9, 2009

Last Update Submit

August 31, 2015

Conditions

Resistant Vascular Ulcers

Outcome Measures

Primary Outcomes (1)

  • Measure of the diameter of the ulcer

    Every week

Study Arms (1)

amniotic membranes

EXPERIMENTAL
Procedure: amniotic membranes

Interventions

amniotic membranesPROCEDURE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Service de Médecine Interne et Pathologie Vasculaire

Bordeaux, 33075, France

Location

Service de Chirurgie Vasculaire et Viscérale

Bordeaux, 33076, France

Location

Service de Chirurgie Thoracique, cardiovasculaire et angiologie

Limoges, 87000, France

Location

Study Officials

  • Francis Pesteil, MD

    CHU Limoges

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2009

First Posted

January 12, 2009

Study Start

January 1, 2009

Primary Completion

December 1, 2013

Study Completion

June 1, 2016

Last Updated

September 1, 2015

Record last verified: 2013-12

Locations

FR(3)