Treatment of the Hypertensive Leg Ulcers by PRF Application

Phase 4

Terminated

• Conditions: Hypertensive Leg Ulcer
• Interventions: Procedure: PRF (Platelet-Rich Fibrin)

• Registration Number: NCT01957124
• Lead Sponsor: University Hospital, Strasbourg, France

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2013-09-25
• Study Start: 2013-10
• Study First Submitted QC: 2013-10-07
• Study First Posted: 2013-10-08
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-07
• Last Update Posted: 2017-09-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PRF application	PRF (Platelet-Rich Fibrin)	-

Primary Outcome Measures

Name	Time	Method
Pain auto evaluation (spontaneous and caused by local care)	Pain was assessed by self-assessment Single Digital Scale - Pain felt in the past 24 hours;	- Pain experienced during the last ulcer care.; Ulcers are described using the: * Size; * Presence or absence of necrosis on the bottom and banks; * Presence or absence of purplish banks

Trial Locations

Locations (1)

Hôpitaux Universitaires; 🇫🇷 Strasbourg, France