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Autologous Skin Substitute for leg ulcers.


- candidate number12356
- NTR NumberNTR3427
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-mei-2012
- Secondary IDsNL32502.000.11 / 2010-021797-10; CCMO / EudraCT
- Public TitleAutologous Skin Substitute for leg ulcers.
- Scientific TitleA phase II randomized multicenter study on efficacy and safety of cultured autologous skin (Tiscover®) and acellular dermal matrix (AS210) in chronic (arterio-)venous ulcers.
- ACRONYM
- hypothesisA prospective, multicenter, randomised controlled phase II study in which patients with therapy resistant (arterio-) venous leg ulcers are treated in an outpatient setting with an autologous cultured human living skin substitute (Tiscover®: test group) or with Acellular donor dermis (AS210: control group) to determine the safety and relative efficacy of both products.
- Healt Condition(s) or Problem(s) studiedChronic (arterio) venous leg ulcers
- Inclusion criteria1. Presence of confirmed venous, arterio-venous ulcer;
2. Patients age over 18 years and under age of 90 years;
3. Ulcer duration over 12 weeks and less than 5 years consecutively;
4. <15% ulcer size reduction in 4 weeks prior to inclusion;
5. Ulcer is between 1-40 cm2 in size;
6. ABPI ≥ 0.7 and < 1.2;
7. Ulcer depth < 1 cm;
8. Mobile, at least able to walk with medical walker, and able to return for required treatments and study evaluations;
9. (Legally) capable to give informed consent;
10. Able to understand and comply with requirements of study protocol.
- Exclusion criteria1. Ulcer chronicity < 12 weeks;
2. >15% increase of ulcer size in 4 weeks prior to inclusion or confirmed by historical data (patient status);
3. Presence of deep vein trombosis or contra indication for compression therapy;
4. Severe co-morbidity reducing life expectance to < 1 year;
5. Use of oral corticosteroids and/or cytostatics >20 mg/per day;
6. Allergies to Gentamycin (which is used in the tissue media), Clindamycin or Ciprofloxacin, or the used local wound treatments;
7. Severe infection of ulcer, active cellulitis, osteomyelitis;
8. Expected non-compliance with compression therapy, protocol treatment or no informed consent;
9. Severe malnutrition;
10. Uncontrolled diabetes mellitus, HbA1c > 12% (108 mmol/mol);
11. Anaemia Hb <6 mmol/l;
12. Current participation in another clinical trial, prior participation in another trial in 3 months.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2012
- planned closingdate31-dec-2014
- Target number of participants49
- InterventionsApplication of skin substitute or acellulair dermis at week 0 and week 1.
- Primary outcome1. Efficacy (Time to heal: time point of healing, Number and percentage of closed ulcers at week 12 and 26);
2. Ulcer size: Percentage of reduction;
3. Safety.
- Secondary outcome1. Recurrence (Number and percentage of recurred ulcers at 3 and 6);
2. Duration of closure;
3. Quality of the healed skin;
4. Quality of life will;
5. Take rate of skin substitute.
- Timepoints12 weeks, 26 weeks, 3 and 6 months follow up.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. S. Gibbs
- CONTACT for SCIENTIFIC QUERIESDr. S. Gibbs
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
A-SKIN Nederland BV, ZON-MW, The Netherlands Organization for Health Research and Development, AgentschapNL
- PublicationsWound 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.
- Brief summaryA prospective, multicenter, randomised controlled phase II study in which patients with therapy resistant (arterio-) venous leg ulcers are treated in an outpatient setting with an autologous cultured human living skin substitute (Tiscover®: test group) or with Acellular donor dermis (AS210: control group) to determine the safety and relative efficacy of both products.
49 adults (> 18 years) admitted for outpatient wound care in the VU medical center or nearby collaborating centers with (arterio-) venous leg ulcers not responding to standard treatment will be selected. A therapy resistant leg ulcer is defined as an ulcer existing for 12 weeks or longer without or with minimal improvement, despite optimal treatment. During a pre-inclusion evaluation period of 4 weeks based on 4 weeks protocol treatment or historical data determination chronicity of ulcer to ensure there is no intention to heal (i.e. size reduction is < 15%) takes place. Patients with leg ulcers between 1 – 40 cm2 will be selected for inclusion.

Intervention:
The test group (33 pts) and control group (AS210 will receive 2 applications (week 0 and week 1). will receive 2 applications of Tiscover® at week 0.
- Main changes (audit trail)
- RECORD9-mei-2012 - 25-mei-2012


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