Autologous Skin Substitute for Chronic Leg/Foot Ulcers.
- Conditions
- Varicose Ulcer
- Interventions
- Drug: TiscoverOther: AS210
- Registration Number
- NCT02360358
- Lead Sponsor
- Chantal Blok
- Brief Summary
A prospective, multicenter, randomised controlled phase II study in which patients with therapy resistant (arterio-) venous leg/foot ulcers are treated with Tiscover® (test group) or with AS210 (control group) to determine the safety and relative efficacy of both products.
- Detailed Description
Multicenter, randomised clinical trial in out patient in which patients with chronic (arterio-) venous leg/foot ulcers are treated with an autologous cultured human living skin substitute (Tiscover®: test group) or with Acellular donor dermis (AS210: control group). During a pre-inclusion evaluation period of 4 weeks (non healing) chronicity of ulcer is ensured (ulcer size change of \< 30%). To determine ulcer type ABI, Doppler and CEAP is performed.
The test group will receive 2 applications of Tiscover®. Week 0: wound activating pre-treatment, application of at least one quarter of the wound surface. Week 1: removal of patches, application of patches on total wound surface.
The control group (16 patients) will follow the same application protocol.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 8
Not provided
- History of anaphylaxis, serum sickness, or erythema multiforme reaction to bovine serum proteins, gentamycin.
- Therapy with another investigational agent within thirty (30) days of Screening, or during the study.
- A target ulcer of non-venous etiologies (e.g., sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma gangrenosum, vasculopathic or vasculitic).
- Documented history of osteomyelitis at the target wound location within 6 months preceding the Screening Visit.
- Refusal of or inability to tolerate compression therapy.
- Therapy of the target ulcer with autologous skin graft, Apligraf™, or Dermagraft™ within 30 days preceding the Screening Visit.
- History of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancers).
- >30% change of wound size in 4 weeks or confirmed by historical data
- Presence of deep vein thrombosis 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;
- Severe infection of ulcer, active cellulitis, osteomyelitis
- Severe malnutrition
- Uncontrolled diabetes mellitus, HbA1c > 12% (108 mmol/mol)
- Anaemia Hb <6 mmol/l
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description autologous cultured skin Tiscover autologous cultured skin patches (Tiscover) is applied on wound in 2-step procedure with 1 week interval. Dosage: number of patches depends on wound size. Application week 0 is removed after one week (week1). Week 1: wound is completely covered with new Tiscover patches. acellular donor dermis AS210 acellular donor dermis (AS210) is applied on wound in 2-step procedure with 1 week interval. Dosage: number of patches depends on wound size. Application week 0 is removed after one week (week1). Week 1: wound is completely covered with new AS210 patches.
- Primary Outcome Measures
Name Time Method Proportion of subjects with complete wound closure after 26 weeks. 26 weeks The primary objective of this study is to demonstrate the superiority of Tiscover® compared to AS210 for achieving wound healing in subjects with a chronic (arterio) venous leg or foot ulcer.
- Secondary Outcome Measures
Name Time Method Time in days to complete wound closure from baseline. 12 weeks • Proportion of subjects with complete wound closure at each of the 12 treatment weeks. 12 weeks Percentage of wound closure 12 and 26 weeks Proportion of subjects with durable wound healing over the 3 months following complete wound closure 3 months and 6 months follow up Wound size reduction 12 and 26 weeks The percentage of reduction in wound area
Pain week 0, 1,2,4,8,12, 26 weeks and follow up Measured with VAS Pain scale
Quality of Life Week 0, 12, 26 weeks and follow up Measured with SF 36
Number of SAE 12, 26 weeks and follow up
Trial Locations
- Locations (5)
St. Fransiscus Gasthuis
🇳🇱Rotterdam, Netherlands
Centrum Oosterwal
🇳🇱Alkmaar, Netherlands
Flevo Ziekenhuis, afdeling dermatologie
🇳🇱Almere, Netherlands
VU University Medical center
🇳🇱Amsterdam, Netherlands
Isala Ziekenhuis, dermatologie
🇳🇱Zwolle, Netherlands