Autologous Conditioned Plasma (ACP) for Patients With Plantar Fasciitis

NCT01614223 | Unknown

• 1 other identifier: FKSCM 2010 -1
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Keywords

Plantar fasciitis; Autologous Conditioned Plasma

Outcome Measures

Primary Outcomes (1)

• American Orthopaedic Foot and Ankle Midfoot Scale (AOFAS)

  Inlcudes subjective and objective assessments and has demonstrated test retest reliability, validity, sensitivity to change and responsiveness for conditions of the foot and ankle. A minimally important change is considered to be at least a 5 point change with an effect size of 0.59.

  6 weeks, 3, 6 and 12 months

Secondary Outcomes (2)

• Plantar Fasciitis Pain/Disability Scale (PFPD

  6 weeks, 3, 6 and 12 months

• SF-12

  6 weeks, 3,6,12 months

Study Arms (2)

ACP treatment

ACTIVE COMPARATOR

Procedure: ACP

Corticosteroid treatment

ACTIVE COMPARATOR

Drug: Corticosteroid (celestone) injection

Interventions

ACP PROCEDURE

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.

ACP treatment

Corticosteroid (celestone) injection DRUG

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.

Corticosteroid treatment

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Western Ontario, Canada: lead
• Arthrex, Inc.: collaborator

Study Sites (1)

Fowler Kennedy Sport Medicine Clinic

London, Ontario, N6A 3K7, Canada

RECRUITING

MeSH Terms

Conditions

Fasciitis, Plantar

Interventions

Adrenal Cortex Hormones; Betamethasone; Injections

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Dianne Bryant, PhD

  The University of Western Ontario

  STUDY DIRECTOR

Central Study Contacts

Dianne Bryant, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 4, 2012
• First Posted: June 7, 2012
• Study Start: September 1, 2010
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: April 25, 2014

Record last verified: 2014-04

Locations

CA (1)