A Phase II Randomized Multicenter Study on Efficacy and Safety of Cultured Autologous Skin (Tiscover®) and Acellular Dermal Matrix (AS210) in Chronic (Arterio-)Venous Ulcers
Overview
- Phase
- Phase 1
- Intervention
- Tiscover
- Conditions
- Varicose Ulcer
- Sponsor
- Chantal Blok
- Enrollment
- 8
- Locations
- 5
- Primary Endpoint
- Proportion of subjects with complete wound closure after 26 weeks.
- Status
- Terminated
- Last Updated
- 10 years ago
Overview
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.
Investigators
Chantal Blok
trial coordinator
Amsterdam UMC, location VUmc
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •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
Arms & Interventions
autologous cultured skin
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.
Intervention: Tiscover
acellular donor dermis
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.
Intervention: AS210
Outcomes
Primary Outcomes
Proportion of subjects with complete wound closure after 26 weeks.
Time Frame: 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 Outcomes
- 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)
- Pain(week 0, 1,2,4,8,12, 26 weeks and follow up)
- Quality of Life(Week 0, 12, 26 weeks and follow up)
- Number of SAE(12, 26 weeks and follow up)