NL-OMON30845
Withdrawn
Not Applicable
a pilot study into the effects and feasibility of the use of Tiscover® (tissue-engineered autologous skin substitute) for chronic ulcers (venous ulcers, diabetic ulcers and decubitus ulcers). - Effects of Tiscover® on chronic ulcers
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- decubitus/diabetic/ venous ulcers
- Sponsor
- Vrije Universiteit Medisch Centrum
- Enrollment
- 20
- Status
- Withdrawn
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •· Venous ulcer, arterio(lo)sclerotic ulcer , decubitus ulcer or diabetic ulcer .
- •· chronic (\>1 month no tendency to heal),
- •· Ulcer 1\-100 cm²
- •· consent (competent)
- •· Ulcus depth \< 1\.0 cm
Exclusion Criteria
- •\- serious comorbidity (lief expectancy \< 6 months)
- •\- use of high dose corticosteroids or cytostatics
- •\- allergy for penicillin
- •\- serious wound infection at t\=0
- •\- refusal of necessary clinical treatments
- •\- incompetent for decision making
Outcomes
Primary Outcomes
Not specified
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