ReNu™ vs. Corticosteroids for the Treatment of Plantar Fasciitis

Fasciitis, Plantar Clinical Trial

Official title:

A Comparative Study of Injectable Human Amniotic Allograft (ReNu™) Versus Corticosteroids for Plantar Fasciitis: A Prospective, Randomized, Blinded Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02982226
• Other study ID #: RD-2015-08-05
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2016
• Est. completion date: April 2021

Study information

• Verified date: April 2020
• Source: NuTech Medical, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this clinical trial is to evaluate both the safety and efficacy of the ReNu™ injection on pain and inflammation in subjects diagnosed with plantar fasciitis as compared to a Corticosteroid Injection which is considered standard of care.

Description:

This is a two (2) arm evaluation in 150 subjects with plantar fasciitis. Patients will be treated with ReNu™(study treatment) or Corticosteroids (control).

At each follow-up visit, concomitant medications and adverse events shall be collected from each subject, and each subject shall complete following questionnaires:

• AOFAS Ankle-Hindfoot Score (AOFAS-AHS)

• Visual Analog Score (VAS)

• Single Answer Numeric Evaluation (SANE)

• Subject Satisfaction Score (at the 6 Month Follow Ups ONLY)

The subjects will be assessed at Baseline (pre-injection) using these scales and again at all subsequent study follow-up visits.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: April 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Ages 18 to 75 inclusive

2. BMI less than 40

3. Actively practicing a contraception method, abstinent, surgically sterile, or post-menopausal (defined as no menses for a minimum of 12 months)

4. Reporting heel pain of >6 on a verbally administered 1-10 pain scale where 1 is no pain and 10 is extreme pain

5. Diagnosed with plantar fasciitis in either foot

6. Completed a minimum of two months of conservative, non-injection treatment/therapies (i.e., activity modification, icing, NSAIDs, orthotics, physical therapy, etc.)

Exclusion Criteria

1. Prior surgery on the affected foot

2. Prior injection treatment for plantar fasciitis within the past 6 months with steroids or tissue engineered materials just in the site seeking treatment

3. Clinical signs and symptoms of infection of foot in question

4. Evidence of significant neurological disease of either foot

5. Non-ambulatory

6. Presence of comorbidities that can be confused with or can exacerbate the condition including, but not limited to the following:

• Calcaneal stress fracture

• Nerve entrapment syndrome, such as Baxter's Nerve Entrapment or Tarsal Tunnel Syndrome

• Plantar Fascial rupture

• Systemic disorders associated with enthesiopathy, i.e., Gout, Reiter's syndrome, rheumatoid arthritis, etc.

• Achilles tendonitis

• Fat Pad Atrophy

• Fibromyalgia

• Diabetic Neuropathy

7. Pregnant, pregnant within the past six (6) months, breast feeding and/or desire to become pregnant during the course of the study, as verified by urine pregnancy test within one week prior to injection.

8. Has taken NSAID medication within the past 14 days, or other pain medication in the past day

9. History of more than two (2) weeks treatment with immuno-suppressants, including systemic corticosteroids or cytotoxic chemotherapy within one month prior to initial screening, or has receive such medications during the screening period, or are anticipated to require such medications during the course of the study.

10. Taking any investigational drug(s) or therapeutic device(s) within 30 days preceding screening

11. History of radiation therapy of the affected foot

12. Known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV

13. Involved in a Worker's Compensation Claim of any kind

14. Unable to understand the objectives of the trial

15. Presence of any condition(s) which, in the opinion of the investigator, would compromise the subject's ability to complete this study

16. Having a known history of poor adherence with medical treatment.

17. Express an unwillingness to receive human allograft tissue

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar

Intervention

Other:
• ReNu Injection
ReNu is an allograft tissue composed of particularized amniotic membrane and cell from the amniotic fluid.
• Corticosteroid Injection
Corticosteroids are considered a standard of care for treatment of Plantar Fasciitis

Locations

Country	Name	City	State
United States	Geisinger	Danville	Pennsylvania
United States	Advanced Orthopedics	Denver	Colorado
United States	Orlando Food and Ankle Clinic	Orlando	Florida
United States	Lower Extremity Institute of Research & Therapy (LEIRT)	Poland	Ohio
United States	The Vancouvover Clinic	Vancouver	Washington
United States	The Iowa Clinic Foot and Ankle Surgery	West Des Moines	Iowa

Sponsors (3)

Lead Sponsor	Collaborator
NuTech Medical, Inc	MileStone Research Organization, Organogenesis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in AOFAS score from baseline		6 months
Secondary	Change in VAS pain score from baseline		6 months
Secondary	Change in SANE function score from baseline		6 months
Secondary	Return to Normal Function between treatment groups	Assessed using questionnaire by the Principal Investigator (PI)	6 months