NCT00758641

Brief Summary

Rationale: 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2009

Longer than P75 for phase_4

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 25, 2008

Completed
11 months until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

March 14, 2017

Status Verified

June 1, 2016

Enrollment Period

6.3 years

First QC Date

September 22, 2008

Last Update Submit

March 13, 2017

Conditions

Plantar Fasciitis

Keywords

plantar fasciitisplatelet rich plasmaGPS

Outcome Measures

Primary Outcomes (1)

  • Percentage of successfully treated patients

    6 months

Secondary Outcomes (4)

  • Pain reduction

    0-12 months

  • Function

    0-12 months

  • Patient satisfaction

    0-12 months

  • Complications and reinventions

    0-12 months

Study Arms (2)

L-PRP Injection

EXPERIMENTAL

L-PRP produced with Biomet Recover L-PRP Platelet Separation Kit

Device: L-PRP Injection

Steroid Injection

ACTIVE COMPARATOR

Corticosteroid injections

Drug: Corticosteroid Injection

Interventions

L-PRP InjectionDEVICE

L-PRP produced with Biomet Recover L-PRP Platelet Separation Kit

L-PRP Injection
Corticosteroid InjectionDRUG

kenacort 40 mg/ml triamcinolon acetonide

Also known as: Corticosteroid
Steroid Injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • No bias to sex
  • \> 18 years
  • Chronic plantar fasciitis or proximal recalcitrant plantar heel pain (6-12 months duration)
  • Failed conservative treatment
  • Able to understand the informed consent
  • VAS pain in morning by first steps higher as 5 (0-10 scale)

You may not qualify if:

  • Received local steroid injections within 6 weeks, physical/occupational therapies within 4 weeks, or non-steroidal anti-inflammatory within 1 week prior to randomization
  • Inability to fulfil follow-up criteria
  • Significant cardiovascular, renal or hepatic disease
  • Pregnant
  • (Local) malignancy
  • History of amenia (hemoglobin \< 5.0 )
  • Previous surgery for plantar fasciitis
  • Active bilateral plantar fasciitis
  • Diagnosis of vascular insufficiency or neuropathy related to heel pain
  • Hypothyroidism
  • Diabetics
  • No other painful or function limited disorders of the foot and ankle

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Haga ziekenhuis

DenHaag, Netherlands

Location

Albert Schweitzer Ziekenhuis

Dordrecht, 3318, Netherlands

Location

Diaconessehuis

Leiden, Netherlands

Location

Academisch Ziekenhuis Maastricht

Maastricht, 6229, Netherlands

Location

St Elisabeth Hospital

Tilburg, Netherlands

Location

Related Publications (2)

  • Peerbooms JC, Lodder P, den Oudsten BL, Doorgeest K, Schuller HM, Gosens T. Positive Effect of Platelet-Rich Plasma on Pain in Plantar Fasciitis: A Double-Blind Multicenter Randomized Controlled Trial. Am J Sports Med. 2019 Nov;47(13):3238-3246. doi: 10.1177/0363546519877181. Epub 2019 Oct 11.

    PMID: 31603721DERIVED

  • Peerbooms JC, van Laar W, Faber F, Schuller HM, van der Hoeven H, Gosens T. Use of platelet rich plasma to treat plantar fasciitis: design of a multi centre randomized controlled trial. BMC Musculoskelet Disord. 2010 Apr 14;11:69. doi: 10.1186/1471-2474-11-69.

    PMID: 20398269DERIVED

MeSH Terms

Conditions

Fasciitis, Plantar

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot Diseases

Intervention Hierarchy (Ancestors)

HormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • T Gosens, MD, PhD

    St Elisabeth Hospital

    PRINCIPAL INVESTIGATOR

  • H.M. Schuller, PhD, MD

    Diaconessehuis Leiden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2008

First Posted

September 25, 2008

Study Start

September 1, 2009

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

March 14, 2017

Record last verified: 2016-06

Locations

NL(5)