Autologous Conditioned Plasma (ACP) for Patients With Plantar Fasciitis

Chronic Plantar Fasciitis Clinical Trial

Official title:

A Randomized Double-Blind Clinical Trial to Investigate the Use of Autologous Conditioned Plasma (ACP) for Patients With Plantar Fasciitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01614223
• Other study ID #: FKSCM 2010 -1
• Status: Recruiting
• Phase: N/A
• First received: June 4, 2012
• Last updated: April 24, 2014
• Start date: September 2010
• Est. completion date: September 2015

Study information

• Verified date: April 2014
• Source: University of Western Ontario, Canada
• Contact: Dianne Bryant, PhD
• Phone: 519-661-2111
• Email: dianne.bryant[@]uwo.ca
• Is FDA regulated: No
• Health authority: Canada: Health Ethics Research Board, The University of Western Ontario
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Plantar Fasciitis
• Fasciitis
• Fasciitis, Plantar

Intervention

Procedure:
• 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.

Drug:
• 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.

Locations

Country	Name	City	State
Canada	Fowler Kennedy Sport Medicine Clinic	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Western Ontario, Canada	Arthrex, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Plantar Fasciitis Pain/Disability Scale (PFPD		6 weeks, 3, 6 and 12 months	No
Secondary	SF-12		6 weeks, 3,6,12 months	No