None listed
Conditions
Interventions
Trade Name: Vivostat PRF
Product Name: Vivostat PRF
Product Code: NA
Pharmaceutical Form: Cutaneous spray, solution
Sponsors
Vivostat A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age: >18 years 2. Type I or Type II Diabetes Mellitus 3. Ulcer(s) at or below the ankle which have been present for at least 4 weeks, and have received best practice care 4. Ulcer area between 0,5 and 16 cm2 after sharp debridement 5. If there is more than one ulcer the investigator shall choose one index ulcer to be treated (typically the largest one). The other ulcers will receive standard care and are not to be included in the study. A maximum of 2 ulcers is allowed at the foot investi-gated 6. Ulcer type: University of Texas grade IA. 7. Evidence of adequate arterial perfusion: Toe pressure reading of = 30 mmHg or if toe is missing, transcutaneous oxygen (TcPO2) of = 30mmHg on the foot. 8. Patient foot is appropriately off loaded (contact cast, pneumatic walking cast) 9. Orthopaedic assessment has been completed to rule out a mechanical source of ulcera-tion 10. Relative wound area reduction less than 50% from week –3 to week 0 (pre-screening period) 11. Signed informed consent 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Clear indication for surgery (vascular reconstruction or skin transplant) 2. Ulcer with exposed bone or tendon 3. Bone involvement (probe to bone or x-ray) 4. Patients with 3 ulcers or more on at the foot investigated 5. Osteomyelitis 6. Clinical signs of infections in the ulcer studied 7. Patients with Necrosis in the ulcer that cannot be removed by debridement at Week 0 8. Patients with known Methicillin-resistant Staphylococcus aureus (MRSA) in the specific ulcer treated in the study 9. Malnutrition. Albumin 12% 12. Male : Hb < 8 g/dl Female : Hb < 7 g/dl 13. Platelet count <140 *109/l 14. Pregnancy and fertile women not practising sufficient birth control 15. Fertile women with a positive pregnancy test week 0 16. Lactating women 17. Patients on haemodialysis 18. Limb ischemia requiring re-vascularisation or impending amputation 19. History of peripheral vascular repair within 4 weeks prior to randomization 20. Bleeding disorders, haemophilia, sickle cell disease, thrombocytopenia, and leukaemia or blood dyscrasias 21. Current treatment for malignancy or neoplastic disease or collagen scular disease 22. Patient has a highly communicable disease or diseases that may limit follow 23. Patients with immuno-compromised conditions, hepatitis, active tuberculosis 24. Patient has inadequate venous access to draw blood 25. History of alcohol or drug abuse within the last year prior to randomization 26. Patient known to have psychological, developmental, physical, emotional or social dis-order or other ailments that may interfere with the study requirements 27. Patients enrolled in an other clinical trial for wound treatment within 30 days prior to enrolment 28. Non-compliance in the screening period 29. Patients who have received growth factor therapy e.g. becaplermin within 7 days prior to enrolment 30. Relative wound area reduction greater than 50% from Week-3 to Week 0 (Run-in)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this pilot study is to evaluate the healing effect of Vivostat® PRF® treatment of diabetic non-ischemic foot ulcers, to identify responders and to enable sample size calculation for a subsequent pivotal trial. Primary effect parameter: Proportion of completely healed ulcers after 12 weeks (defined as 100 % epithelialisation);Secondary Objective: Secondary effect parameters: - Time to complete healing - Percentage of patients with a 50% reduction of wound area after 4 weeks and 8 weeks - Granulation rate (the area covered with new granulation tissue) - Number of infections - The extend of maceration - Treatment time - Time used for kit preparation and blood donation at each treatment - Time used for application of PRF at each treatment ;Primary end point(s): Proportion of completely healed ulcers after 12 weeks (defined as 100 % epithelialisation) | — |
Countries
Germany
Outcome results
None listed