Micronized dHACM Injectable for the Treatment of Achille Tendonitis

Completed · Phase 3

Conditions studied: Tendonitis;Achilles

In brief

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

Key facts

Study ID

NCT03414255

Run by

MiMedx Group, Inc.

People needed

146

Starts

2018-01-09

Expected to finish

2021-03-30

Last updated by the study team

2022-05-19

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All subjects enrolled must meet all the following 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:
• Rest, Ice, Compression, Elevation (RICE)
• Stretching exercises
• Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
• Orthotics
• 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 Any potential subjects meeting any of the following criteria will be excluded from enrollment and subsequent randomization.
• 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:
• Calcaneal stress fracture
• Suspected partial thickness tear of the Achilles tendon, as assessed by the investigator
• Calcaneal tumor
• Tarsal tunnel syndrome (diagnosed)
• Significant bone deformity of the foot that may interfere with the study

Where it is running

• Central Research Associates — Birmingham, Alabama, United States
• Southern Arizona VA Health Care System — Tucson, Arizona, United States
• ILD Research Center — Carlsbad, California, United States
• Foot and Ankle Clinic — Los Angeles, California, United States
• Five Cities Foot Clinic — Pismo Beach, California, United States
• South Florida Veterans Affairs — Miami, Florida, United States
• Doctors Research Network — Miami, Florida, United States
• Northside Podiatry — Buford, Georgia, United States
• Foot and Ankle Center of Illinois — Springfield, Illinois, United States
• Advanced Foot & Ankle Center — Las Vegas, Nevada, United States
• University Orthopedics Center — Altoona, Pennsylvania, United States
• West Penn Hospital — Pittsburgh, Pennsylvania, United States
• Futuro Clinical Trials — McAllen, Texas, United States
• Coastal Podiatry, Inc. — Virginia Beach, Virginia, United States

Full record on ClinicalTrials.gov

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