Treatment of the Hypertensive Leg Ulcers by PRF Application

University Hospital, Strasbourg, France

Status and phase: Terminated; Phase 4

Conditions: Hypertensive Leg Ulcer

Treatments: Procedure: PRF (Platelet-Rich Fibrin)

Study type: Interventional

Funder types: Other

Identifiers

NCT01957124

5377

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• hypertensive leg ulcer
• important pain (>= 5/10)

Exclusion criteria

• significant venous deficiency
• significant arterial deficiency
• other leg ulcers
• any active diseases such as infection, neoplasia, auto-immune disease

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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10 participants in 1 patient group

PRF application

Experimental group

Treatment:

Procedure: PRF (Platelet-Rich Fibrin)