CompletedPhase 3

Micronized dHACM Injectable for the Treatment of Achille Tendonitis

United States146 participantsStarted 2018-01-09

Plain-language summary

Prospective, Double-Blinded, Randomized Controlled Trial of the Micronized dHACM Injection as Compared to Saline Placebo Injection in the Treatment of Achilles Tendonitis

Who can participate

Age range21 Years – 80 Years

SexALL

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Inclusion criteria

✓. Confirmed diagnosis of Achilles tendonitis for ≥ 1 month (30 days) and ≤ 18 months by the investigator
✓. VAS Pain scale of ≥ 45 at randomization
✓. Achilles Tendonitis with conservative treatment for ≥1 month (30 days) while under the direction of the healthcare provider, including any of the following modalities:
✓. Diagnostic AP and lateral X-Ray within 6 months of enrollment showing view of calcaneus negative for calcaneal fracture or structural abnormalities
✓. BMI ≤ 40 kg/m2
✓. Age from 21 to 80 years
✓. Ability to sign Informed Consent and Release of Medical Information Forms
✓. Ability to receive and respond to text messages or emails on a daily basis.

Exclusion criteria

✕. Prior surgery to the affected site.
✕. Subjects requiring bilateral Achilles tendonitis 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 diagnosed comorbidities that can be confused with or can exacerbate the condition- to be assessed by X-ray - including but not limited to:
✕. The presence of diagnosed comorbidities that require surgery or are unlikely to improve - to be assessed by Investigator-including but not limited to:
✕. Affected site exhibits clinical signs and symptoms of infection

What they're measuring

Change in VAS score

Timeframe: 90 days

Incidence of adverse events

Timeframe: 365 days

Trial details

NCT IDNCT03414255

SponsorMiMedx Group, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-03-30

View on ClinicalTrials.gov More Tendonitis;Achilles trials