Treatment of the Hypertensive Leg Ulcers by PRF Application

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2013 by University Hospital, Strasbourg, France
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT01957124
First received: September 25, 2013
Last updated: October 7, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Hypertensive Leg Ulcer
Procedure: PRF (Platelet-Rich Fibrin)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of the Hypertensive Leg Ulcers by PRF Application

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • Pain auto evaluation (spontaneous and caused by local care) [ Time Frame: Pain was assessed by self-assessment Single Digital Scale - Pain felt in the past 24 hours; ] [ Designated as safety issue: No ]

    - 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


Estimated Enrollment: 18
Study Start Date: October 2013
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PRF application Procedure: PRF (Platelet-Rich Fibrin)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01957124

Contacts
Contact: Jean-Nicolas Scrivener 03 88 11 66 28 Jean-Nicolas.scrivener@chru-strasbourg.fr

Locations
France
Hôpitaux Universitaires Not yet recruiting
Strasbourg, France, 67098
Contact: Jean-Nicolas Scrivener    03 88 11 66 28    jean-nicolas.scrivener@chru-strasbourg.fr   
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Jean-Nicolas Scrivener Hôpitaux Universitaires de Strasbourg
  More Information

No publications provided

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT01957124     History of Changes
Other Study ID Numbers: 5377
Study First Received: September 25, 2013
Last Updated: October 7, 2013
Health Authority: France: ANSM

Additional relevant MeSH terms:
Leg Ulcer
Ulcer
Skin Ulcer
Skin Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014