Recruitment for and information about the study of chronic (arterio) venous ulcera in the VU medical center
Last September 2012, the Dermatology department of the VUmc represented by the dermatologists Dr. Edith M. de Boer and Dr. Bibi (C) van Montfrans, started a Phase-II study on the efficacy of cultured skin tissue for the treatment of chronic open leg wounds.
In cooperation with several external clinics, efficacy of Tiscover® (cultured autologous skin tissue) is compared with AS210 (acellular donor skin) in patients with a therapy-resistant (arterio) venous ulcus cruris. Both products, Tiscover ® and AS210, are produced by A-SKIN. The appropriate legislation authorities (IGZ) granted the required manufacturing and research licenses.
Study now open for patient inclusion (2012- 2014)
Participation in this study is possible for patients meeting the following inclusion criteria (in short):
Note: Administration of more than 20 mg (>20 mg) Prednisone dd or cytostatics will lead to exclusion of the study.
In this study two outpatient treatments are compared: 2x application of Tiscover® or 2x AS210 (donor skin). Distribution over the groups is determined by drawing lots. The treatment is painless. For the Tiscover® cohort it is necessary to obtain skin biopsies for the skin tissue culture.
In the study period of 26 weeks (maximum: depending on the speed of wound closure) the patient will visit the consulting dermatologist weekly in the outpatient clinic for checkups. Consecutive appointments will follow 3 and 6 months after the ulcus has healed.
Both products, Tiscover® and the a-cellular donor skin, are still in a development phase and are not commercially available. For clinical applications under the Hospital Exemption regulation see below.
Other participants in this study are: Slotervaart Hospital (Amsterdam, Centrum Oosterwal (Alkmaar), Flevo Hospital (Almere), Ziekenhuisgroep Twente, locatie Hengelo; Sint Franciscus Gasthuis, Rotterdam and the Isala Clinic, Zwolle.
If you want to nominate a patient or require more information, please contact the research team by email to firstname.lastname@example.org or call + 31 (0)20 4442624 (Monday, Wednesday, and Thursday). This study is also made possible by a ZonMW grant. If you want more information about this promising new treatment we are happy to explain it more extensively.