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

MiMedx

Status: Terminated

Conditions: Plantar Fasciitis

Treatments: Procedure: Injection of 1.0 cc of 10 mg/ml micrograft dHACM suspension; Procedure: Injection of 1.0 cc of 40 mg/ml micrograft dHACM suspension; Procedure: Injection of 1.0 cc of 20 mg/ml micrograft dHACM suspension; Procedure: Injection of 1.0 cc of 0.9% Saline

Study type: Interventional

Funder types: Industry

Identifiers

NCT01996111

AIPF003

Details and patient eligibility

About

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).

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

---

14 participants in 4 patient groups, including a placebo group

• Group 2:

Experimental group

Description:

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

Treatment:

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

• Group 3:

Experimental group

Description:

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

Treatment:

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

• Group 4:

Experimental group

Description:

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

Treatment:

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

• Group 1

Placebo Comparator group

Description:

• Injection of 1.0 cc of 0.9% Saline

Treatment:

Procedure: Injection of 1.0 cc of 0.9% Saline