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Micronized dHACM Injectable for the Treatment of Plantar Fasciitis

CompletedPhase 2, Phase 3NCT02427191
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

Prospective, single-blinded, randomized controlled trial of the micronized dHACM injection as compared to the saline placebo injection in the treatment of plantar fasciitis

Study details

Official title
A Prospective, Single-Blinded, Randomized Controlled Trial of the Micronized dHACM Injection as Compared to the Saline Placebo Injection in the Treatment of Plantar Fasciitis
Conditions
  • Fasciitis, Plantar
Interventions
  • Other: AmnioFix® Injectable
  • Drug: Saline Injection
Sponsor
MiMedx Group, Inc.
Start date
2015-03-31
Primary completion
2018-08
Sex
All
Age range
from 21 Years to 79 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
11

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Confirmed diagnosis of plantar fasciitis for ≥ 1 month (30 days) and ≤ 18 months by the investigator 2. VAS Pain scale of ≥ 45 mm at randomization 3. Plantar fasciitis with conservative treatment for ≥ 1 month (30 days), including any of the following modalities: * RICE * Stretching exercises * NSAIDs * Orthotics 4. Diagnostic X-Ray within 6 months of enrollment showing view of calcaneus negative for calcaneal fracture or structural abnormalities 5. BMI ≤ 40 kg/m2 6. Age ≥ 21 years and \< 80 7. Ability to sign Informed Consent and Release of Medical Information Forms Exclusion Criteria: 1. Prior surgery or trauma to the affected site 2. Subjects requiring bilateral plantar fasciitis treatment at time of enrollment 3. Prior use of any lower limb injection therapy, including corticosteroids or PRP in either limb within the last 3 months 4. Has diabetes either Type I or Type II 5. Systemic disorders associated with enthesopathy (disorder of entheses, i.e. bone attachments) such as Gout, Reiter's syndrome, rheumatoid arthritis, etc. 6. The presence of comorbidities that can be confused with or can exacerbate the condition- to be assessed by X-ray - including but not limited to: * Calcaneal stress fracture * Nerve entrapment syndrome (Baxter Nerve Syndrome) * Fat pad atrophy * Acute traumatic rupture of the plantar fascia * Calcaneal tumor * Tarsal tunnel syndrome * Significant bone deformity of the foot that may interfere with the study 7. Affected site exhibits clinical signs and symptoms of infection 8. Known allergy or known sensitivity to Aminoglycosides, such as Gentamicin sulfate or Streptomycin sulfate 9. Clinically significant abnormal laboratory tests at baseline, including CBC, PT/PTT/INR, liver function and creatinine, as determined by the investigator 10. Patients who are non-ambulatory 11. History of more than 14 days treatment with immuno-suppressants (including systemic corticosteroids) or cytotoxic chemotherapy within 30 days prior to enrollment, or who are anticipated to require such medications during the course of the study 12. Prior radiation at the site 13. Use of any investigational drug(s) or therapeutic device(s) within 3 months preceding enrollment 14. Immune disorders including Systemic Lupus Erythematosus (SLE), Fibromyalgia, Acquired Immunodeficiency Syndrome (AIDS) or Human Immunodeficiency Virus (HIV) 15. History of any condition (including drug or alcohol abuse, medical or psychiatric condition) that is lik…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02427191