Micronized dHACM Injectable for the Treatment of Plantar Fasciitis
CompletedPhase 3NCT03414268
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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, double-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 Phase 3, Prospective, Double-Blinded, Randomized Controlled Trial of the Micronized dHACM Injection As Compared To Saline Placebo Injection In The Treatment Of Plantar Fasciitis
- Conditions
- Fasciitis, Plantar
- Interventions
- Other: Micronized dHACM
- Drug: Saline Injection
- Sponsor
- MiMedx Group, Inc.
- Start date
- 2018-01-08
- Primary completion
- 2021-03-17
- Sex
- All
- Age range
- from 21 Years to 79 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 17
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 years 7. Ability to sign Informed Consent and Release of Medical Information Forms 8. Ability to receive and respond to text messages or emails on a daily basis. 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 diagnosed 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 (diagnosed as Baxter Nerve Syndrome) * Fat pad atrophy * Acute traumatic rupture of the plantar fascia * Calcaneal tumor * Tarsal tunnel syndrome (diagnosed) * 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 9. Subjects who are non-ambulatory 10. 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 11. Prior radiation at the site 12. Use of any investigational drug(s) or therapeutic device(s) within 3 months preceding enrollment 13. Immune disorders including Systemic Lupus Erythematosus (SLE), Fibromyalgia, Acquired Immunodeficiency Syndrome (AIDS) or Human Immunodeficiency Virus (HIV) 14. History of any condition (including drug or alcohol abuse, medical or psychiatric condition) that is likely to impair understanding of or compliance with the study protocol, in the judgment of …
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03414268