Hypertensive Leg Ulcer Clinical Trial
Official title:
Treatment of the Hypertensive Leg Ulcers by PRF Application
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.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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|
Phase 3 | |
| Completed |
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|
Phase 4 |