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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
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertensive Leg Ulcer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 25, 2013
Last Updated
September 7, 2017
Sponsor
University Hospital, Strasbourg, France
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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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