Micronized dHACM Injectable for the Treatment of Achille Tendonitis

NCT03414255 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: AIAT001
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 14

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

Conditions

Tendonitis;Achilles

Keywords

Chronic Achilles Tendonitis

Outcome Measures

Primary Outcomes (2)

• Change in VAS score

  Visual Analog Scale, Left end point is "No Pain". Right end point is "worst pain imaginable"

  90 days

• Incidence of adverse events

  The incidence of related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events during the first 12 months post injection

  365 days

Secondary Outcomes (1)

• Foot Function Index Revised (FFI-R) (Short Form)

  90 days

Study Arms (2)

Micronized DHACM

EXPERIMENTAL

1mL injection of 40mg Micronized dehydrated human amnion/chorion membrane (DHACM)

Biological: Micronized DHACM

Saline Injection

PLACEBO COMPARATOR

Injection of 1mL 0.9% Sodium Chloride Injection, USP

Drug: Saline Injection

Interventions

Micronized DHACM BIOLOGICAL

1 mL injection of 40mg Micronized dehydrated human amnion/chorion membrane (DHACM).

Also known as: dHACM

Micronized DHACM

Saline Injection DRUG

Injection of 1mL 0.9% Sodium Chloride Injection, USP

Also known as: 0.9% NaCL, Normal Saline, Sodium Chloride Injection, USP

Saline Injection

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

You may not qualify if:

• 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

Sponsors & Collaborators

• MiMedx Group, Inc.: lead

Study Sites (14)

Central Research Associates

Birmingham, Alabama, 35205, United States

Location

Southern Arizona VA Health Care System

Tucson, Arizona, 85723, United States

Location

ILD Research Center

Carlsbad, California, 92009, United States

Location

Foot and Ankle Clinic

Los Angeles, California, 90057, United States

Location

Five Cities Foot Clinic

Pismo Beach, California, 93449, United States

Location

South Florida Veterans Affairs

Miami, Florida, 33125, United States

Location

Doctors Research Network

Miami, Florida, 33143, United States

Location

Northside Podiatry

Buford, Georgia, 30518, United States

Location

Foot and Ankle Center of Illinois

Springfield, Illinois, 62704, United States

Location

Advanced Foot & Ankle Center

Las Vegas, Nevada, 89119, United States

Location

University Orthopedics Center

Altoona, Pennsylvania, 16602, United States

Location

West Penn Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

Futuro Clinical Trials

McAllen, Texas, 78501, United States

Location

Coastal Podiatry, Inc.

Virginia Beach, Virginia, 23464, United States

Location

MeSH Terms

Interventions

Sodium Chloride; Saline Solution

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Stuart D Miller, MD

  MedStar Union Memorial Hospital Baltimore, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: January 29, 2018
• Study Start: January 9, 2018
• Primary Completion: March 30, 2021
• Study Completion: March 30, 2021
• Last Updated: May 19, 2022

Record last verified: 2020-05

Locations

US (14)