Autologous Skin Substitute for leg ulcers.
Completed
- Conditions
- chronic (arterio) venous leg ulcers
- Registration Number
- NL-OMON23091
- Lead Sponsor
- Free University medical center (VUmc)
- Brief Summary
Wound healing in venous ulcers; mechanisms, approach and modern developments. Gibbs S, van den Hoogenband HM, de Boer EM. Ned Tijdschr Geneeskd. 2007 Mar 17;151(11):635-40. Review. Dutch. Autologous full-thickness skin substitute for healing chronic wounds.Gibbs S, van den Hoogenband HM, Kirtschig G, Richters CD, Spiekstra SW, Breetveld M, Scheper RJ, de Boer EM. Br J Dermatol. 2006 Aug;155(2):267-74.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 49
Inclusion Criteria
1. Presence of confirmed venous, arterio-venous ulcer;
2. Patients age over 18 years and under age of 90 years;
Exclusion Criteria
1. Ulcer chronicity < 12 weeks;
2. >15% increase of ulcer size in 4 weeks prior to inclusion or confirmed by historical data (patient status);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Efficacy (Time to heal: time point of healing, Number and percentage of closed ulcers at week 12 and 26);<br /><br>2. Ulcer size: Percentage of reduction;<br /><br>3. Safety.
- Secondary Outcome Measures
Name Time Method 1. Recurrence (Number and percentage of recurred ulcers at 3 and 6);<br /><br>2. Duration of closure;<br /><br>3. Quality of the healed skin;<br /><br>4. Quality of life will;<br /><br>5. Take rate of skin substitute.