An open, randomized, (out-patient) clinical study into the effectiveness, durability and cost efficiency of Tiscover® (cultured, autologous skin) for chronic leg wounds (ulcera cruris)

ISRCTN	ISRCTN86386707
DOI	https://doi.org/10.1186/ISRCTN86386707
Protocol serial number	NTR439
Sponsor	VU University Medical Centre (VUMC) (Netherlands)
Funder	The Netherlands Organisation for Scientific Research (Nederlandse Organisatie voor Wetenschappelijk Onderzoek [NWO]) (Netherlands) Biopartner First Stage Grant

Submission date: 27/01/2006
Registration date: 27/01/2006
Last edited: 14/08/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr E.M. Boer, de
Scientific

VU University Medical Center
Department of Dermatology
De Boelelaan 1117
Amsterdam
1081 HV
Netherlands

Phone	+31 (0)20 4444444
Email	em.dboer@vumc.nl

Study information

Primary study design	Interventional
Study design	Multicentre randomised open label active controlled parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	TISCOVER
Study objectives	We hypothesize that ulcers treated with Tiscover® will significantly decrease in size resulting in most cases in full healing, compared to the control group which is not treated with Tiscover®.
Ethics approval(s)	Received from local medical ethics committee
Health condition(s) or problem(s) studied	Ulcera cruris venosa, ulcera cruris arterio(lo)scleroticum, ulcers of mixed origin
Intervention	Two out-patient groups: Control group (n = 30): 1 week prior wound bed preparation with acellular allodermis Test group (n = 30): 1 week prior wound bed preparation with acellular allodermis followed by removal of allodermis and application of Tiscover® Two in-patient groups: Control group (n = 20): 5 day prior wound bed preparation with Vacuum Assisted Closure therapy (VAC) Test group (n = 20): 5 day prior wound bed preparation with VAC followed by application of Tiscover® All patients receive compression therapy. All patients have a weekly follow-up for the duration of 24 weeks.
Intervention type	Other
Primary outcome measure(s)	Effectiveness of treatment of therapy resistant, chronic ulcera cruris (>5 months open; >2 months with no sign of healing), with Tiscover®.
Key secondary outcome measure(s)	1. Determine whether hospitalization and wound bed preparation have a beneficial effect 2. Evaluate unforeseen toxicity due to Tiscover® treatment 3. Evaluate the durability of treatment with Tiscover® 4. Determine whether out-patient treatment with Tiscover® is possible 5. Compare the costs of Tiscover® treatment with present costs for caring/treatment of inert ulcera cruris without Tiscover®
Completion date	15/10/2007

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	100
Key inclusion criteria	1. Ulcus cruris venosum, ulcus cruris arterio(lo)scleroticum and ulcers of mixed origin 2. Non-vital ulcers which exist for at least 5 months and which do not respond to adequate compression therapy and local wound treatment 3. Ulcers between 5 and 100 square cm 4. Signed informed consent 5. Ankle/arm index >0.7
Key exclusion criteria	1. Diabetic foot ulcers 2. Serious co-morbidity which decreases the life expectancy to less than 2 years 3. Use of high doses of corticosteroids and/or cytostatic drugs (>20 mg/day) 4. Diagnosed Penicillin allergy 5. Serious infection of the ulcer bed at time t = 0 6. Disturbances of psychiatric nature where the following of medical advice becomes a problem 7. Declining clinical treatment and/or follow up visits
Date of first enrolment	15/10/2005
Date of final enrolment	15/10/2007

Locations

Countries of recruitment

Netherlands

Study participating centre

VU University Medical Center

Amsterdam
1081 HV
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan