Clinical trial NCT03414255: Micronized dHACM Injectable for the Treatment of Achille Tendonitis
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 Achilles Tendonitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tendonitis;Achilles
Keywords: Chronic Achilles Tendonitis
Lead sponsor: MiMedx Group, Inc.
Sponsor class: INDUSTRY
First posted: 2018-01-29
Enrollment: 146
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: Approximately 158 subjects will be enrolled in this study. Each patient will receive 1 injection and be evaluated for efficacy and safety during a 12 month observation period. Randomization will be 1:1. The study is expected to be completed in 24 months, inclusive of enrollment and follow-up of all subjects.

Eligibility criteria: Inclusion Criteria

All subjects enrolled must meet all the following criteria:

1. Confirmed diagnosis of Achilles tendonitis for ≥ 1 month (30 days) and ≤ 18 months by the investigator
2. VAS Pain scale of ≥ 45 at randomization
3. 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
4. Diagnostic AP and lateral 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 from 21 to 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 Any potential subjects meeting any of the following criteria will be excluded from enrollment and subsequent randomization.

1. Prior surgery to the affected site.
2. Subjects requiring bilateral Achilles tendonitis 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
   * 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
7. 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
8. Affected site exhibits clinical signs and symptoms of infection
9. Known allergy or known sensitivity to Aminoglycosides
10. Subjects who are non-ambulatory
11. 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
12. Prior radiation at the site
13. Use of any investigational drug(s) or therapeutic device(s) within 3 months preceding enrollment
14. Immune system disorders including Systemic Lupus Erythematosus (SLE), Fibromyalgia, Acquired Immunodeficiency Syndrome (AIDS), Human Immunodeficiency Virus (HIV) or Lyme disease
15. 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
16. 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)
17. Workers' compensation patients

Primary outcomes:
measure: Change in VAS score
timeFrame: 90 days
measure: Incidence of adverse events
timeFrame: 365 days
Secondary outcomes:
measure: Foot Function Index Revised (FFI-R) (Short Form)
timeFrame: 90 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Central Research Associates
state: Alabama
city: Tucson
country: United States
facility: Southern Arizona VA Health Care System
state: Arizona
city: Carlsbad
country: United States
facility: ILD Research Center
state: California
city: Los Angeles
country: United States
facility: Foot and Ankle Clinic
state: California
city: Pismo Beach
country: United States
facility: Five Cities Foot Clinic
state: California
city: Miami
country: United States
facility: South Florida Veterans Affairs
state: Florida
city: Miami
country: United States
facility: Doctors Research Network
state: Florida
city: Buford
country: United States
facility: Northside Podiatry
state: Georgia
city: Springfield
country: United States
facility: Foot and Ankle Center of Illinois
state: Illinois
city: Las Vegas
country: United States
facility: Advanced Foot & Ankle Center
state: Nevada
city: Altoona
country: United States
facility: University Orthopedics Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: West Penn Hospital
state: Pennsylvania
city: McAllen
country: United States
facility: Futuro Clinical Trials
state: Texas
city: Virginia Beach
country: United States
facility: Coastal Podiatry, Inc.
state: Virginia
Study officials:
affiliation: MedStar Union Memorial Hospital Baltimore, MD
name: Stuart D Miller, MD
role: PRINCIPAL_INVESTIGATOR
References: