Autologous Skin Substitute for leg ulcers

• Conditions: The autologous cultured skin substitute (Tiscover) or acellular donor dermis (AS210) is applied to patients with chronic (arterio-) venous leg wounds.; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2010-021797-10-NL
• Lead Sponsor: VU university medical center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-23
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

•Presence of confirmed venous, arterio-venous.
•Patients age over 18 years and under age of 90 years.
•Ulcer duration over 12 weeks and less than 5 years consecutively
•<15% ulcer size reduction in 4 weeks prior to inclusion
•Ulcer is between 1-40 cm2 in size
•ABPI = 0.7 and < 1.2
•Ulcer depth < 1 cm
•Mobile, at least able to walk with medical walker, and able to return for required treatments and study evaluations
•(Legally) capable to give informed consent
•Able to understand and comply with requirements of study protocol

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 49
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 49

Exclusion Criteria

•Ulcer chronicity < 12 weeks
•>15% increase of ulcer size in 4 weeks prior to inclusion or confirmed by historical data (patient status)
•Presence of deep vein trombosis or contra indication for compression therapy
•Severe co-morbidity reducing life expectance to < 1 year
•Use of oral corticosteroids and/or cytostatics >20 mg/per day;
•Allergies to Gentamycin (which is used in the tissue media), Clindamycin or Ciprofloxacin, or the used local wound treatments
•Severe infection of ulcer, active cellulitis, osteomyelitis
•Expected non-compliance with compression therapy, protocol treatment or no informed consent
•Severe malnutrition
•Uncontrolled diabetes mellitus, HbA1c > 12% (108 mmol/mol)
•Anaemia Hb <6 mmol/l
•Current participation in another clinical trial, prior participation in another trial in 3 months.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified