Treatment of the Hypertensive Leg Ulcers by PRF Application
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|ClinicalTrials.gov Identifier: NCT01957124|
Recruitment Status : Terminated
First Posted : October 8, 2013
Last Update Posted : September 8, 2017
Hypertensive leg ulcers are very painful and difficult to treat ulcers. Their treatment is not well established.
We want to study the efficacy of PRF applications on the pains related to those ulcers.
PRF (Platelet-Rich Fibrin) is an autologous fibrin clot, obtained extemporaneously from patient's blood, without any additive nor complex manipulation. It contains blood platelets and white blood cells, trapped in fibrin during clot formation.
PRF (Platelet-Rich Fibrin) is form immediately after blood punction in a dry tube, that does not contain any anticoagulant. Coagulation naturally occurs within few minutes, and tubes are placed in a centrifuge: red blood cells are separated from the fibrin clot thanks to difference of density, and blood platelets and white blood cells are trapped in the fibrin clot.
The fibrin clot is then rapidly applicated on the ulcer surface for four days. Our hypothesis is that platelet growth factors and cytokines, liberated during platelet activation, could help to treat hypertensive leg ulcers, that are caused by a vascular spasm.
|Condition or disease||Intervention/treatment||Phase|
|Hypertensive Leg Ulcer||Procedure: PRF (Platelet-Rich Fibrin)||Phase 4|
2 to 8 PRF (depending on the ulcer surface), applied on painful hypertensive leg ulcer, and covered by a dressing for 4 days.
Afterwards, dressings are made in a classical way. If needed (persistence of important pain), the PRF application can be repeated after 7 days.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Treatment of the Hypertensive Leg Ulcers by PRF Application|
|Actual Study Start Date :||October 2013|
|Actual Primary Completion Date :||July 2017|
|Actual Study Completion Date :||July 2017|
|Experimental: PRF application||
Procedure: PRF (Platelet-Rich Fibrin)
- Pain auto evaluation (spontaneous and caused by local care) [ Time Frame: Pain was assessed by self-assessment Single Digital Scale - Pain felt in the past 24 hours; ]
- Pain experienced during the last ulcer care.
Ulcers are described using the:
- Presence or absence of necrosis on the bottom and banks
- Presence or absence of purplish banks
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01957124
|Strasbourg, France, 67098|
|Principal Investigator:||Jean-Nicolas Scrivener||Hôpitaux Universitaires de Strasbourg|