Outcomes of Autologous Whole Blood Injection for the Treatment of Plantar Fasciitis

NCT05589285 | Unknown DMC

• 1 other identifier: MREC 2864
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the effectiveness of whole blood injection as a safe and effective method of treatment of chronic plantar fasciitis. The hypothesis is that Autologous whole blood (AWB) injection is more effective than sham injections in the treatment of plantar fasciitis. Participants will receive an autologous whole blood injection over the plantar fascia, and will be followed up to study the response. Researchers will compare the effects with a control group who will receive normal saline injection.

Conditions

Plantar Fascitis

Keywords

plantar fasciitis; Whole blood injection

Outcome Measures

Primary Outcomes (4)

• Visual Analog Scale

  Visual Analog Scale (VAS) to assess the pain score from 0 (minimum) to 10 (maximum)

  12 months

• Foot Function Index

  a questionnaire based index to assess the foot function (from 0% minimum to 100% maximum)

  12 months

• Foot and Ankle Ability Measure (FAAM)

  a questionnaire based index to assess foot and ankle ability in various daily life activities.

  12 months

• Change in Plantar fascia thickness

  Measurement of the change in plantar fascia thickness using ultrasound

  before the treatment and 12 months after the treatment.

Study Arms (2)

Treatment group

EXPERIMENTAL

Chronic plantar fasciitis patients who will receive autologous whole blood injection.

Biological: Injection of autologous whole blood to the plantar fascia

Control group

SHAM COMPARATOR

Chronic plantar fasciitis patients who will receive normal saline injection.

Device: Injection of normal saline to the plantar fascia

Interventions

Injection of autologous whole blood to the plantar fascia BIOLOGICAL

Patients assigned in this group will have 2 ml of blood withdrawn from a peripheral vein, then mixed with 1 mL Lidocaine 2% for a total of 3mL volume in one syringe. The patient will be asked to lie down in the clinic bed, and the injection will be administered to the plantar fascia by the principal investigator using a sterile technique.

Treatment group

Injection of normal saline to the plantar fascia DEVICE

This will be the control group receiving sham injection. Patients will have 2 ml of blood withdrawn from a peripheral vein for blinding proposes. They will be asked to lie down on the clinic bed, 1 ml of normal saline will be administered under sterile technique by the principal investigator. The blood that was withdrawn initially will be discarded.

Control group

Eligibility Criteria

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

You may qualify if:

• Patients with chronic plantar fasciitis (persistence of symptoms despite 12 weeks of conservative management)
• Age: adults patients more than 18 years
• Not having responded to primary conservative managements such as rest, shoe insoles, conventional physical therapy, exercise therapy, and nonsteroidal anti-inflammatory drugs (NSAIDs).

You may not qualify if:

• Neurological or vascular insufficiencies in the painful heel
• Osteomyelitis, fracture of the calcaneus
• Recent infection in the treatment area, history of rheumatic diseases
• Immunosuppressive therapy or coagulation disturbance and/or therapy, long-term treatment with corticosteroids
• Previous heel surgery
• Patient with diabetes mellitus,
• Pregnancy
• Received corticosteroid injection
• Four weeks since the last anaesthetic injection, iontophoresis, ultrasound and
• electromyostimulation

Sponsors & Collaborators

• Sultan Qaboos University: lead

Study Sites (1)

Sultan Qaboos Univeristy Hospital

Muscat, Oman

RECRUITING

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Study Officials

• Wafa Al Baluki

  Sultan Qaboos University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wafa Al Baluki, BSc, MD, FRCSC.

CONTACT

+968 71 9999 31; albaluki@squ.edu.om

Asma Al Rasbi, MD

CONTACT

+968 97767028; asma.alrasbi@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant foot and ankle orthopaedics surgeon

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: October 21, 2022
• Study Start: July 13, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2025
• Last Updated: January 29, 2024

Record last verified: 2024-01

Locations

OM (1)