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 |
| Secondary identifying numbers | NTR439 |
- 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
Scientific
VU University Medical Center
Department of Dermatology
De Boelelaan 1117
Amsterdam
1081 HV
Netherlands
| Phone | +31 (0)20 4444444 |
|---|---|
| em.dboer@vumc.nl |
Study information
| Study design | Multicentre randomised open label active controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 15/10/2005 |
| Completion date | 15/10/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 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
1081 HV
Netherlands
Sponsor information
VU University Medical Centre (VUMC) (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Dermatology
De Boelelaan 1117
Amsterdam
1081 HV
Netherlands
"ROR" |
https://ror.org/00q6h8f30 |
|---|
Funders
Funder type
Research council
The Netherlands Organisation for Scientific Research (Nederlandse Organisatie voor Wetenschappelijk Onderzoek [NWO]) (Netherlands) Biopartner First Stage Grant
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
