Condition category
Circulatory System
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
14/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr E.M. Boer, de

ORCID ID

Contact details

VU University Medical Center
Department of Dermatology
De Boelelaan 1117
Amsterdam
1081 HV
Netherlands
+31 (0)20 4444444
em.dboer@vumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR439

Study information

Scientific title

Acronym

TISCOVER

Study hypothesis

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

Received from local medical ethics committee

Study design

Multicentre randomised open label active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Effectiveness of treatment of therapy resistant, chronic ulcera cruris (>5 months open; >2 months with no sign of healing), with Tiscover®.

Secondary outcome measures

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®

Overall trial start date

15/10/2005

Overall trial end date

15/10/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

100

Participant 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

Recruitment start date

15/10/2005

Recruitment end date

15/10/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

VU University Medical Center
Amsterdam
1081 HV
Netherlands

Sponsor information

Organisation

VU University Medical Centre (VUMC) (Netherlands)

Sponsor details

Department of Dermatology
De Boelelaan 1117
Amsterdam
1081 HV
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research council

Funder name

The Netherlands Organisation for Scientific Research (Nederlandse Organisatie voor Wetenschappelijk Onderzoek [NWO]) (Netherlands) Biopartner First Stage Grant

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes