Treatment of the Hypertensive Leg Ulcers by PRF Application

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2017-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hypertensive Leg Ulcer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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PRF application

Group Type EXPERIMENTAL

PRF (Platelet-Rich Fibrin)

Intervention Type PROCEDURE

Interventions

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PRF (Platelet-Rich Fibrin)

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No