None listed
Conditions
Brief summary
The aim of this study is to test the efficacy of platelet-rich plasma on improving healing in venous ulcer and its effect in reducing local pain while also examining occurrence of any possible side effects.
Interventions
Platelet rich plasma (PRP) is applied to the wound bed every week during the 24 week intervention period. During each application wound will be cleaned with soapy chlorhexidine and normal saline. PRP is then instilled onto the wound bed using PRGF technique (Registered Trademark) making sure that entire wound bed area is covered. Wound is then covered with Mepitel (Registered Trademark) contact layers followed by new gauze dressing and a single layer of pressure bandage. 72 hours (3 days) and 5
Platelet rich plasma (PRP) is applied to the wound bed every week during the 24 week intervention period. During each application wound will be cleaned with soapy chlorhexidine and normal saline. PRP is then instilled onto the wound bed using PRGF technique (Registered Trademark) making sure that entire wound bed area is covered. Wound is then covered with Mepitel (Registered Trademark) contact layers followed by new gauze dressing and a single layer of pressure bandage. 72 hours (3 days) and 5 days after each PRP instillation, standard care is administered. Ulcer care and administration of PRP are performed by the principal investigator, a specialist nurse under the supervision of medical specialist in surgery
Sponsors
School of nursing, physiotherapy and podiatry, University of Sevilla
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-Patient venous ulcer etiology with more than 6 weeks evolution. -Age, +18 years. -Unassisted ambulation by others or need to brace for activities of daily living activities. -Ankle-arm index more than 0.8 and less than 1.2 in the presence of ulcer member. - Not have undergone surgery for the treatment of venous insufficiency before or during treatment with PRP. -Tolerance one layer for compressive therapy.
Exclusion criteria
- Critical thrombocytopenia, definedas aplatelet count 150.000/ul. - Hemoglobin level below 10g /dl. -Drug therapy: NSAIDs (7 days), systemic corticosteroids(15 days), immunosuppressants, cytotoxic chemotherapy, antiplatelet and anticoagulation. -Platelet dysfunction syndrome. - Hemodynamic instability. - Autoimmune disease. - Oncological disease. -Liver disease. - Septicemia. - Poorly controlled diabetes. - Morbid obesity. - Renal insufficiency.
Outcome results
None listed