Efficacy and safety of platelet-rich plasma in venous ulcer.

Not Applicable

Completed

• Conditions: venous ulcer healing; local pain in venous ulcer; Skin - Dermatological conditions; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

• Registration Number: ACTRN12615001112550
• Lead Sponsor: School of nursing, physiotherapy and podiatry, University of Sevilla

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 94

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
% Reduction in ulcer surface area.<br>Calculated the difference in percentage of the initial surface to the end surface.To calculate the surface of the ulcer of the ellipse formula was used.<br>A = length x width x 0.675[ 24 weeks after randomization];pain reduction as visual analog pain scale[24 weeks after randomization]

Secondary Outcome Measures

Name	Time	Method
Secondary effects after application of platelet-rich plasma.<br>The side effects are rated local infection and irritative dermatitis. Are valued according to visual inspection of the principal investigator once a week according observation of the following signs: increased exudate, increasing pain, itching, erythema periulcer.[Every week for 24 weeks]