Treatment of the Hypertensive Leg Ulcers by PRF Application

NCT01957124 | Terminated Phase 4

• 1 other identifier: 5377
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertensive Leg Ulcer

Outcome Measures

Primary Outcomes (1)

• 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

  Pain was assessed by self-assessment Single Digital Scale - Pain felt in the past 24 hours;

Study Arms (1)

PRF application

EXPERIMENTAL

Procedure: PRF (Platelet-Rich Fibrin)

Interventions

PRF (Platelet-Rich Fibrin) PROCEDURE

PRF application

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• hypertensive leg ulcer
• important pain (\>= 5/10)

You may not qualify if:

• significant venous deficiency
• significant arterial deficiency
• other leg ulcers
• any active diseases such as infection, neoplasia, auto-immune disease

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Hôpitaux Universitaires

Strasbourg, 67098, France

Location

MeSH Terms

Interventions

Prolactin-Releasing Hormone

Intervention Hierarchy (Ancestors)

Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Jean-Nicolas Scrivener

  Hôpitaux Universitaires de Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2013
• First Posted: October 8, 2013
• Study Start: October 1, 2013
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: September 8, 2017

Record last verified: 2017-09

Locations

FR (1)