Status:
UNKNOWN
Plasma Rich Growth Factors in Venous Ulcers
Lead Sponsor:
Basque Health Service
Conditions:
Venous Ulcers
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
OBJECTIVES: Main objective: To evaluate the effectiveness of plasma rich in growth factors (PRGF) in the treatment of patients with venous ulcers. Secondary objective: To evaluate the safety of plasma...
Detailed Description
An open, randomized, of parallel groups, and controlled clinical trial. Patients will be allocated on first come to one of the two treatment groups using a block random sequence generated by computer ...
Eligibility Criteria
Inclusion
- Older than 18 years.
- Patients with at least one venous ulcer of at least 6 weeks of evolution.
- Diameter between 0,5-6cm.
Exclusion
- Cutaneous ulcers with an arterial and/or mixed origin.
- Ankle-arm index \<0.9.
- Concomitant terminal disease with bad prognosis.
- Hematologic several abnormalities (anemia with hemoglobin \<11g/dl, hematocrit \<34%, lymphomas and leukemias).
- Antineoplastic or immunosuppressive treatment.
- Solid tumors.
- Nutritional status affectation.
- Known peripheral neuropathy in patients with diabetes mellitus.
- At home patient.
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2013
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT01491438
Start Date
November 1 2013
End Date
November 1 2013
Last Update
February 7 2013
Active Locations (1)
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1
Javier Urraca García de Madinabeitia
Vitoria-Gasteiz, Álava, Spain