Varicose Ulcer
Conditions
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.
Interventions
DRUGTiscover
two step procedure, week 0 and week1. Dosage depends on wound size.
OTHERAS210
two step procedure, week 0 and week1. Dosage depends on wound size.
Sponsors
ZonMw: The Netherlands Organisation for Health Research and Development
Chantal Blok
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have a (arterio) venous leg ulcer (VLU) between the knee and ankle (at or above the malleolus), or on foot (not plantar side of the foot) with a surface area ≥ 1.0 cm2 and ≤ 40.0 cm2 * Venous insufficiency confirmed by duplex Doppler ultrasound examination for valvular or venous incompetence. * Arterial supply adequacy confirmed (ABPI ≥ 0.6 and ≤ 1.3) * Target ulcer involves a full thickness skin loss, but WITHOUT exposure of tendon, muscle, or bone. Ulcer depth \< 1 cm * Target ulcer duration ≥ 12 weeks but ≤ 15 years * Acceptable state of health and nutrition * Mobile, at least able to walk with medical walker, and able to return for required treatments and study evaluations
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| • 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 | — |
| Time in days to complete wound closure from baseline. | 12 weeks | — |
| 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 | — |
| Wound size reduction | 12 and 26 weeks | The percentage of reduction in wound area |
Countries
Netherlands
Outcome results
None listed