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

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

Sponsors

Lead Sponsor: MiMedx Group, Inc.

Source MiMedx Group, Inc.
Brief 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).

Overall Status Terminated
Start Date September 2013
Completion Date April 2014
Primary Completion Date March 2014
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Reduction of inflammation as measured by AOFAS Hindfoot scores 8 Weeks
Secondary Outcome
Measure Time Frame
Return to normal activities more quickly than with standard of care 8 Weeks
Pain as measured by 0-10 Numeric Rating Scale 12 weeks
Enrollment 14
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Injection of 1.0 cc of 0.9% Saline

Description: Injection of 1.0 cc of 0.9% Saline into affected area

Arm Group Label: • Group 1

Intervention Type: Procedure

Intervention Name: Injection of 1.0 cc of 10 mg/ml micrograft dHACM suspension

Description: Injection of 1.0 cc of 10 mg/ml micrograft dHACM suspension into affected area

Arm Group Label: • Group 2:

Intervention Type: Procedure

Intervention Name: Injection of 1.0 cc of 20 mg/ml micrograft dHACM suspension

Description: Injection of 1.0 cc of 20 mg/ml micrograft dHACM suspension into affected area

Arm Group Label: • Group 3:

Intervention Type: Procedure

Intervention Name: Injection of 1.0 cc of 40 mg/ml micrograft dHACM suspension

Description: Injection of 1.0 cc of 40 mg/ml micrograft dHACM suspension into affected area

Arm Group Label: • Group 4:

Eligibility

Criteria:

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Charles M. Zelen, DPM Principal Investigator Professional Education and Research Institute
Location
Facility: Professional Education and Research Institute
Location Countries

United States

Verification Date

June 2014

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: • Group 2:

Type: Experimental

Description: Injection of 1.0 cc of 10 mg/ml micrograft dHACM suspension

Label: • Group 3:

Type: Experimental

Description: Injection of 1.0 cc of 20 mg/ml micrograft dHACM suspension

Label: • Group 4:

Type: Experimental

Description: Injection of 1.0 cc of 40 mg/ml micrograft dHACM suspension

Label: • Group 1

Type: Placebo Comparator

Description: • Injection of 1.0 cc of 0.9% Saline

Acronym dHACM
Study Design Info

Allocation: Randomized

Intervention Model: Factorial Assignment

Primary Purpose: Treatment

Masking: Single (Participant)

Source: ClinicalTrials.gov