Dehydrated Human Amnion/Chorion Membrane Micrografts(dHACM) Injectable in the Treatment of Recalcitrant Plantar Fasciitis

Plantar Fasciitis Clinical Trial

— dHACM  

Official title:

A Prospective, Randomized, Controlled, Blinded, Comparative Study of Dehydrated Human Amnion/Chorion Membrane Micrografts(dHACM) Injectable in the Treatment of Recalcitrant Plantar Fasciitis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01996111
• Other study ID #: AIPF003
• Status: Terminated
• Phase: N/A
• First received: October 10, 2013
• Last updated: June 12, 2014
• Start date: September 2013
• Est. completion date: April 2014

Study information

• Verified date: June 2014
• Source: MiMedx Group, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This is a prospective, controlled, randomized, blinded and comparative, single-center clinical trial comparing the improvement of patients with recalcitrant plantar fasciitis symptoms that have received standard of care versus treatment with differing amounts of injectable dehydrated human amnion/chorion membrane micrografts(dHACM).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: April 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. At least 18 years old.

2. Both male and female patients will be selected.

3. Plantar fasciitis has been treated with conservative usual care for at least 8 weeks, including at least three of the following modalities

• Rest, Ice, Compression, Elevation (RICE)

• Corticosteroid injection

• Stretching exercises

• Non-steroidal Anti-Inflammatory Drugs (NSAIDs)

• Orthotics

4. Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence).

5. Patient understands and is willing to participate in the clinical study and can comply with weekly visits and the follow-up regimen.

6. Patient has read and signed the IRB/IEC approved Informed Consent Form before screening procedures are undertaken.

Exclusion Criteria

1. Prior surgery at the site.

2. Site that exhibits clinical signs and symptoms of infection.

3. History of chronic plantar fasciitis of more than twelve months.

4. Evidence of significant neurological disease of the feet.

5. Non-ambulatory patients.

6. The presence of comorbidities that can be confused with or can exacerbate the condition including:

• Calcaneal stress fracture

• Nerve entrapment syndrome (Baxter's Nerve Entrapment or Tarsal Tunnel Syndrome)

• Plantar fascial rupture

• Systemic disorders associated with enthesiopathy (such as Gout, Reiter's syndrome, rheumatoid arthritis, etc.)

• Achilles tendonitis

• Fat pad atrophy

• Fibromyalgia

• Diabetics with neuropathy

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

8. Patients on any investigational drug(s) or therapeutic device(s) within 30 days preceding screening.

9. History of radiation therapy at the site.

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

11. Study foot has been previously treated with tissue engineered materials within the last 30 days.

12. Patients who are unable to understand the aims and objectives of the trial.

13. Presence of any condition(s) which seriously compromises the subject's ability to complete this study, or has a known history of poor adherence with medical treatment.

14. Pregnant or breast feeding. No pregnancy within the past 6 months.

15. Allergy to Gentamicin and/or Streptomycin.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fasciitis

Intervention

Procedure:
• Injection of 1.0 cc of 0.9% Saline
Injection of 1.0 cc of 0.9% Saline into affected area
• Injection of 1.0 cc of 10 mg/ml micrograft dHACM suspension
Injection of 1.0 cc of 10 mg/ml micrograft dHACM suspension into affected area
• Injection of 1.0 cc of 20 mg/ml micrograft dHACM suspension
Injection of 1.0 cc of 20 mg/ml micrograft dHACM suspension into affected area
• Injection of 1.0 cc of 40 mg/ml micrograft dHACM suspension
Injection of 1.0 cc of 40 mg/ml micrograft dHACM suspension into affected area

Locations

Country	Name	City	State
United States	Professional Education and Research Institute	Roanoke	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
MiMedx Group, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of Life as measured by SF-36	SF-36 scores between all groups before and after treatment over a period of eight weeks. Physical Component Score (PCS) and Mental Component Score (MCS) will be evaluation at 8 weeks and compared to baseline	8 weeks	No
Primary	Reduction of inflammation as measured by AOFAS Hindfoot scores	The primary objective of this study is to compare the efficacy of the different treatment amounts in reduction of inflammation as measured by AOFAS Hindfoot scores.	8 Weeks	Yes
Secondary	Return to normal activities more quickly than with standard of care	The secondary objective is to demonstrate that patients treated with micronized dHACM injectable will return to normal activities more quickly than with standard of care.	8 Weeks	Yes
Secondary	Pain as measured by 0-10 Numeric Rating Scale	Patient pain scores will be assessed between all groups.	12 weeks	No