Treatment of the Hypertensive Leg Ulcers by PRF Application

Hypertensive Leg Ulcer Clinical Trial

Official title:

Treatment of the Hypertensive Leg Ulcers by PRF Application

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01957124
• Other study ID #: 5377
• Status: Terminated
• Phase: Phase 4
• First received: September 25, 2013
• Last updated: September 7, 2017
• Start date: October 2013
• Est. completion date: July 2017

Study information

• Verified date: September 2017
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertensive Leg Ulcer
• Leg Ulcer
• Ulcer

Intervention

Procedure:
• PRF (Platelet-Rich Fibrin)

Locations

Country	Name	City	State
France	Hôpitaux Universitaires	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain auto evaluation (spontaneous and caused by local care)	- 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	Pain was assessed by self-assessment Single Digital Scale - Pain felt in the past 24 hours;