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Autologous Skin Substitute for Chronic Leg/Foot Ulcers.

NCT02360358 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2016-01-07

No results posted yet for this study

Summary

A prospective, multicenter, randomised controlled phase II study in which patients with therapy resistant (arterio-) venous leg/foot ulcers are treated with Tiscover® (test group) or with AS210 (control group) to determine the safety and relative efficacy of both products.

Conditions

  • Varicose Ulcer

Interventions

DRUG

Tiscover

two step procedure, week 0 and week1. Dosage depends on wound size.

OTHER

AS210

two step procedure, week 0 and week1. Dosage depends on wound size.

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Chantal Blok

    lead OTHER

Principal Investigators

  • Susan Gibss, Prof.dr. · VU medical center, department of dermatology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02360358 on ClinicalTrials.gov