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Treatment of the Hypertensive Leg Ulcers by PRF Application

U

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

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

10 participants in 1 patient group

PRF application
Experimental group
Treatment:
Procedure: PRF (Platelet-Rich Fibrin)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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