A phase II randomized multicenter study on efficacy and safety of cultured autologous skin (Tiscover®) and acellular dermal matrix (AS210) in chronic (arterio-)venous ulcers.

Free University medical center (VUmc)0 sites49 target enrollmentTBD

Conditionschronic (arterio) venous leg ulcers

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: chronic (arterio) venous leg ulcers
Sponsor: Free University medical center (VUmc)
Enrollment: 49
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

Wound healing in venous ulcers; mechanisms, approach and modern developments. Gibbs S, van den Hoogenband HM, de Boer EM. Ned Tijdschr Geneeskd. 2007 Mar 17;151(11):635-40. Review. Dutch. Autologous full-thickness skin substitute for healing chronic wounds.Gibbs S, van den Hoogenband HM, Kirtschig G, Richters CD, Spiekstra SW, Breetveld M, Scheper RJ, de Boer EM. Br J Dermatol. 2006 Aug;155(2):267-74.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Investigators

Sponsor

Free University medical center (VUmc)

Eligibility Criteria

Inclusion Criteria

•1\. Presence of confirmed venous, arterio\-venous ulcer;
•2\. Patients age over 18 years and under age of 90 years;

Exclusion Criteria

•1\. Ulcer chronicity \< 12 weeks;
•2\. \>15% increase of ulcer size in 4 weeks prior to inclusion or confirmed by historical data (patient status);

Outcomes

Primary Outcomes

Not specified

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