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Treatment of the Hypertensive Leg Ulcers by PRF Application

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ClinicalTrials.gov Identifier: NCT01957124
Recruitment Status : Terminated
First Posted : October 8, 2013
Last Update Posted : September 8, 2017
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Hypertensive Leg Ulcer Procedure: PRF (Platelet-Rich Fibrin) Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
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
Actual Study Start Date : October 2013
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PRF application Procedure: PRF (Platelet-Rich Fibrin)



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

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

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