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Treatment of the Hypertensive Leg Ulcers by PRF Application

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01957124
First Posted: October 8, 2013
Last Update Posted: September 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
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; ]

    - 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


Enrollment: 10
Actual Study Start Date: October 2013
Study Completion Date: July 2017
Primary Completion Date: July 2017 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01957124


Locations
France
Hôpitaux Universitaires
Strasbourg, France, 67098
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Jean-Nicolas Scrivener Hôpitaux Universitaires de Strasbourg
  More Information

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT01957124     History of Changes
Other Study ID Numbers: 5377
First Submitted: September 25, 2013
First Posted: October 8, 2013
Last Update Posted: September 8, 2017
Last Verified: September 2017

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