Autologous Conditioned Plasma (ACP) for Patients With Plantar Fasciitis

NCT ID: NCT01614223

Last Updated: 2014-04-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2015-09-30

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

ACP treatment

Group Type: ACTIVE_COMPARATOR

ACP

Intervention Type: 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.

Corticosteroid treatment

Group Type: ACTIVE_COMPARATOR

Corticosteroid (celestone) injection

Intervention Type: 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.

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.

Intervention Type: PROCEDURE

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arthrex, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Western Ontario, Canada

OTHER

Sponsor Role: lead

Responsible Party

Dianne Bryant

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dianne Bryant, PhD

Role: STUDY_DIRECTOR

The University of Western Ontario

Locations

Fowler Kennedy Sport Medicine Clinic

London, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Dianne Bryant, PhD

Role: CONTACT

dianne.bryant@uwo.ca

519-661-2111 ext. 80349

Other Identifiers

FKSCM 2010 -1

Identifier Type: -

Identifier Source: org_study_id