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).
Withdrawn
- Conditions
- decubitus/diabetic/ venous ulcers10040790
- Registration Number
- NL-OMON30845
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 20
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>% decrease of ulcer</p><br>
- Secondary Outcome Measures
Name Time Method <p>pain, quality of life, satisfaction patient and caregivers</p><br>