CompletedPhase 2/3

Micronized dHACM Injectable for the Treatment of Plantar Fasciitis

United States147 participantsStarted 2015-03-31

Plain-language summary

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

Who can participate

Age range21 Years – 79 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Confirmed diagnosis of plantar fasciitis for ≥ 1 month (30 days) and ≤ 18 months by the investigator
✓. VAS Pain scale of ≥ 45 mm at randomization
✓. Plantar fasciitis with conservative treatment for ≥ 1 month (30 days), including any of the following modalities:
✓. Diagnostic X-Ray within 6 months of enrollment showing view of calcaneus negative for calcaneal fracture or structural abnormalities
✓. BMI ≤ 40 kg/m2
✓. Age ≥ 21 years and \< 80
✓. Ability to sign Informed Consent and Release of Medical Information Forms

Exclusion criteria

✕. Prior surgery or trauma to the affected site
✕. Subjects requiring bilateral plantar fasciitis treatment at time of enrollment
✕. Prior use of any lower limb injection therapy, including corticosteroids or PRP in either limb within the last 3 months
✕. Has diabetes either Type I or Type II
✕. Systemic disorders associated with enthesopathy (disorder of entheses, i.e. bone attachments) such as Gout, Reiter's syndrome, rheumatoid arthritis, etc.
✕. 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:
✕. Affected site exhibits clinical signs and symptoms of infection
✕. Known allergy or known sensitivity to Aminoglycosides, such as Gentamicin sulfate or Streptomycin sulfate

What they're measuring

20% improvement over baseline Visual Analog Scale for Pain

Timeframe: 3 Months

Incidence of adverse events

Timeframe: 12 months

Trial details

NCT IDNCT02427191

SponsorMiMedx Group, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-08

View on ClinicalTrials.gov More Fasciitis, Plantar trials