Research with human participants

Overview of medical research in the Netherlands

Use of PRP to treat plantar fasciitis, blinded and randomized as a multi center study

Published:
Last updated:

To compare the efficacy of autologous platelet concentrate injections with corticosteroid injection in patients suffering from plantar fasciitis with respect to pain and function.

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Ethical review
Approved WMO
Status
Recruitment stopped
Health condition type
Tendon, ligament and cartilage disorders
Study type
Observational non invasive

ID

NL-OMON32073

Source

ToetsingOnline

Brief title

PRP to treat Plantar fasciitis

Condition

  • Tendon, ligament and cartilage disorders

Synonym

plantar fasciitis, policeman's heel

Research involving

Human

Sponsors and support

Primary sponsor :
Sint Elisabeth Ziekenhuis
Source(s) of monetary or material Support :
Biomet Nederland BV

Intervention

Keyword :
blood, plantar fasciitis, platelet gel

Outcome measures

Primary outcome

Pain and function measured with questionnaires

Secondary outcome

nvt

Background summary

The standard treatment of chronic plantar fasciitis is corticosteroid
injections. Corticosteroid injection give temporarily pain reduction, but no
healing. Blood platelets initiate the natural healing rate. GPS ® gives an
eightfold concentrate platelets of patients own blood. Injection of these
platelets in the tendon might induce a healing rate.

Study objective

To compare the efficacy of autologous platelet concentrate injections with
corticosteroid injection in patients suffering from plantar fasciitis with
respect to pain and function.

Study design

Randomized, double blinded, multi center trial

Study burden and risks

Because autologous blood is used no extra risks are expected as standard for
injection in the tendon

Public
Biomet Nederland BV

Hilvarenbeekseweg 60
5000 LC Tilburg
NL
Scientific
Biomet Nederland BV

Hilvarenbeekseweg 60
5000 LC Tilburg
NL

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

Inclusion criteria

> 18 years
Chronic plantar fasciitis or proximal recalcitrant heel pain (range 3-12 months)
Failed conservative treatment

Exclusion criteria

Received local steroid injections within 6 weeks, physical/occupational therapies within 4 weeks, or non-steroidal anti-inflammatories within 1 week prior
ignificant cardiovascular, renal or hepatic disease
Prior surgery for Achilles condition
Pregnant
No informed consent

Design

Study phase :
4
Study type :
Observational non invasive
Intervention model
:
Parallel
Allocation :
Randomized controlled trial
Masking :
Double blinded (masking used)
Control :
Active
Primary purpose :
Treatment

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
120
Type :
Actual

Medical products/devices used

Generic name :
Autologous platelet gel
Registration
:
Yes - CE intended use
Product type :
Medicine
Brand name :
Corticosteroids
Generic name :
triamcinolon acetonide
Registration
:
Yes - NL intended use

Approved WMO
Date :
Application type :
First submission
Review commission :
METC Brabant (Tilburg)
Approved WMO
Date :
Application type :
First submission
Review commission :
METC Brabant (Tilburg)
Approved WMO
Date :
Application type :
Amendment
Review commission :
METC Brabant (Tilburg)
Approved WMO
Date :
Application type :
Amendment
Review commission :
METC Brabant (Tilburg)

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
EudraCT EUCTR2008-001257-18-NL
CCMO NL22305.008.08