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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRF application | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRF (Platelet-Rich Fibrin) | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain auto evaluation (spontaneous and caused by local care) | - Pain experienced during the last ulcer care. Ulcers are described using the:
| Pain was assessed by self-assessment Single Digital Scale - Pain felt in the past 24 hours; |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Nicolas Scrivener | Hôpitaux Universitaires de Strasbourg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpitaux Universitaires | Strasbourg | 67098 | France |
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| ID | Term |
|---|---|
| D056690 | Prolactin-Releasing Hormone |
| ID | Term |
|---|---|
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |