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Active Clinical Trials

Micronized dHACM Injectable for the Treatment of Achille Tendonitis

Active NCT:
03414255
West Penn Hospital
West Penn Hospital

Category:
Bone and Muscle
Sponsor: 
MiMedx Group, Inc.
Contact: 

For more information, please contact Kathryn Duffill by telephone at 412-688-7910 or email at Kathryn.Duffill@ahn.org .

A Phase 3, Prospective, Double-Blinded, Randomized Controlled Trial of the Micronized dHACM Injection as Compared to Saline Placebo Injection in the Treatment of Achilles Tendonitis

Purpose: 

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

Ages Eligible for Study:  21 Years to 80 Years   (Adult, Older Adult)

Sexes Eligible for Study:  All

Accepts Healthy Volunteers:  No

Inclusion Criteria

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

The presence of diagnosed comorbidities that require surgery or are unlikely to improve - to be assessed by Investigator-including but not limited to:

Nerve entrapment syndrome

Acute traumatic rupture of the Achilles tendon

Partial thickness tears of the Achilles Tendon

Affected site exhibits clinical signs and symptoms of infection

Known allergy or known sensitivity to Aminoglycosides

Subjects who are non-ambulatory

History of more than 14 days of treatment with immune-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

Prior radiation at the site

Use of any investigational drug(s) or therapeutic device(s) within 3 months preceding enrollment

Immune system disorders including Systemic Lupus Erythematosus (SLE), Fibromyalgia, Acquired Immunodeficiency Syndrome (AIDS), Human Immunodeficiency Virus (HIV) or Lyme disease

History of any conditions (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 the investigator

Pregnancy at enrollment or within last 6 months, women who are breastfeeding, or women of childbearing potential who are planning to become pregnant during the time of the study OR are unwilling/unable to use acceptable methods of contraception (birth control pills, barriers, or abstinence)

Workers' compensation patients