Treatment of the Hypertensive Leg Ulcers by PRF Application
Primary Purpose
Hypertensive Leg Ulcer
Status
Terminated
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
PRF (Platelet-Rich Fibrin)
Sponsored by
About this trial
This is an interventional treatment trial for Hypertensive Leg Ulcer
Eligibility 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
Sites / Locations
- Hôpitaux Universitaires
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PRF application
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01957124
First Posted
September 25, 2013
Last Updated
September 7, 2017
Sponsor
University Hospital, Strasbourg, France
1. Study Identification
Unique Protocol Identification Number
NCT01957124
Brief Title
Treatment of the Hypertensive Leg Ulcers by PRF Application
Official Title
Treatment of the Hypertensive Leg Ulcers by PRF Application
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Terminated
Study Start Date
October 2013 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertensive Leg Ulcer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PRF application
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
PRF (Platelet-Rich Fibrin)
Primary Outcome Measure Information:
Title
Pain auto evaluation (spontaneous and caused by local care)
Description
- 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
Time Frame
Pain was assessed by self-assessment Single Digital Scale - Pain felt in the past 24 hours;
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Nicolas Scrivener
Organizational Affiliation
Hôpitaux Universitaires de Strasbourg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpitaux Universitaires
City
Strasbourg
ZIP/Postal Code
67098
Country
France
12. IPD Sharing Statement
Learn more about this trial
Treatment of the Hypertensive Leg Ulcers by PRF Application
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