ulcera cruris venosa, ulcera cruris arterio(lo)scleroticum and ulcers of mixed origin
Conditions
Interventions
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 Vacume 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 followup for the duration of 24
Sponsors
NWO-Biopartner First Stage Grant
Eligibility
Inclusion criteria
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 centimeters; 4. Signed informed consent; 5. Ankle / arm index >0.7.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness of treatment of therapy resistent, chronic ulcera cruris (>5 months open; >2 months with no sign of healing), with Tiscover. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactE.M. Boer, de
VU University Medical Center, Department of Dermatology, De Boelelaan 1117
Outcome results
None listed