Recruiting

ACP

Sponsor:

University of Western Ontario, Canada

Code:

NCT01614223

Conditions

Chronic Plantar Fasciitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ACP

Corticosteroid (celestone) injection

Study Details

Brief summary:

Plantar fasciitis presents clinically as pain in the inner heal, which is the result of degeneration of the plantar fascia, an arch supporting ligament of the foot. It manifests predominantly in those subjected to sustained weight bearing or repetitive pounding activities. Plantar fasciitis is the most common cause of inferior foot pain. Although most cases resolving within 6 months, traditional treatment regiments such as orthotics and physiotherapy are occasionally unsuccessful in treating this limitation leading to chronic symptoms (Neufeld \& Cerrato, 2008; Rompe, 2009; Roxas, 2005).

Platelets are central players in clotting, inflammation and the wound healing response. Research has shown the potential of platelet rich plasma to accelerate wound healing in a variety of conditions including maxillo-fascial and plastic surgery, chronic wound healing and orthopaedics. Autologous Conditioned Plasma (ACP) is a novel treatment that may accelerate the healing of injured tissue. Treatment with ACP involves taking a blood sample from the patient, isolating the platelets and injecting them back into that patient at the injury site

Conditions

Chronic Plantar Fasciitis

Study ID

NCT01614223

Start date

Sep, 2010

Status verified date

Apr, 2014

Completion date

Sep, 2015

Anticipated

Primary completion date

Sep, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Painful inner heel pain for longer than three months
  • at least six weeks since last corticosteroid injection
  • four weeks since the last anaesthetic injection, iontophoresis, ultrasound and electromyostimulation
  • one week since the last NSAIDs taken
  • two days since the last analgesic, heat, ice, message, stretching, or modification of night splints and orthosis.
  • scores greater or equal to 5 on the VAS PFPD scale
  • scores greater or equal 30 on the AOFAS scale
  • scores of greater or equal to 5 on the VAS PFPD scale and 30 on the AOFAS scale

Exclusion Criteria:

  • tendon rupture
  • neurological or vascular insufficiencies in the painful heel
  • bilateral heel pain
  • Paget's disease or calcaneal fat pad atrophy
  • osteomyelitis, fracture of the calcaneus, ankle inflammation
  • recent infection in the treatment area, history of rheumatic diseases
  • collagenosis or metabolic disorders
  • immunosuppressive therapy or coagulation disturbance and/or therapy, long-term treatment with corticosteroids
  • previous heel surgery
  • malignant disease, diabetes mellitus, severe cardiac or respiratory disease, significant abnormalities in hepatic function
  • participation in another clinical study at the same time.

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: ACP treatment

active comparator: Corticosteroid treatment

Interventions

ACP

Within two weeks of the initial visit, the RN, will retrieve a 10-12 mL blood sample from all patients. After the sample is retrieved, the patient will be asked to lie prone on the plinth to assist with blinding. The blood sample will be retained in the Arthrex ABS-10010S Double Syringe with Syringe Cap and then separated using a soft spin centrifuge for 5 min at 1500 rpm/rcf. Three to four mL of platelet rich plasma will be pulled into a smaller syringe that is wrapped in opaque tape to conceal the contents of the syringe. The ACP is injected into the torn region of the tendon.

Corticosteroid (celestone) injection

Preparation of the blood sample is identical for patients in this group except that the blood sample will ultimately be discarded instead of injected. The syringe is blinded with opaque tape making it identical to the ACP group syringe and injected into the torn area of the tendon.

Primary outcome measure

  • American Orthopaedic Foot and Ankle Midfoot Scale (AOFAS) [ Time Frame: 6 weeks, 3, 6 and 12 months ]

Central Contacts and Locations

Central contacts

Dianne Bryant, PhD

519-661-2111dianne.bryant@uwo.ca

Locations

Fowler Kennedy Sport Medicine Clinic

Recruiting

London, Ontario, Canada, N6A 3K7

Principal Investigator:

Kevin Willits, Md, FRCSC

More Information

Sponsor

University of Western Ontario, Canada

Last update posted

Apr 25, 2014

Last verified

Apr, 2014

Keywords

  • Plantar fasciitis
  • Autologous Conditioned Plasma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Western Ontario, Canada on 2014-04-25.