Micronized dHACM Injectable for the Treatment of Achille Tendonitis



Status:Recruiting
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:21 - 80
Updated:11/16/2018
Start Date:January 9, 2018
End Date:December 2019
Contact:Stanley J Harris
Email:sharris@mimedx.com
Phone:770-651-9100

Use our guide to learn which trials are right for you!

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

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

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.

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
We found this trial at
19
sites
1819 Buford Highway Northeast
Buford, Georgia 30518
Principal Investigator: Jay Spector, DPM
?
mi
from
Buford, GA
Click here to add this to my saved trials
8042 Wurzbach Road
San Antonio, Texas 78229
210-949-0807
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Altoona, Pennsylvania 16602
Principal Investigator: Alexis Ley, DPM
?
mi
from
Altoona, PA
Click here to add this to my saved trials
3280 Howell Mill Road Northwest
Atlanta, Georgia 30327
Principal Investigator: Charles Garten, MD
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Birmingham, Alabama 35205
Principal Investigator: Jeffrey Davis, MD
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Carlsbad, California 92009
Principal Investigator: Dean Vayser, DPM
?
mi
from
Carlsbad, CA
Click here to add this to my saved trials
Fresno, California 93721
Principal Investigator: Shawn Cazzell, DPM
Phone: 559-431-1700
?
mi
from
Fresno, CA
Click here to add this to my saved trials
Las Vegas, Nevada 89119
Principal Investigator: Cyaandi Dove, DPM
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Los Angeles, California 90010
Principal Investigator: Felix Sigal, DPM
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
McAllen, Texas 78501
Principal Investigator: Joseph Caporusso, DPM
?
mi
from
McAllen, TX
Click here to add this to my saved trials
Miami, Florida 33125
Principal Investigator: Jimmy Trang, DPM
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami, Florida 33143
Principal Investigator: Jason Hanft, DPM
?
mi
from
Miami, FL
Click here to add this to my saved trials
Midlothian, Virginia 23114
?
mi
from
Midlothian, VA
Click here to add this to my saved trials
Pismo Beach, California 93449
Principal Investigator: Brian O'Carroll, DPM
?
mi
from
Pismo Beach, CA
Click here to add this to my saved trials
4800 Friendship Avenue
Pittsburgh, Pennsylvania 15206
Principal Investigator: Alan R. Catanzariti, DPM
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Springfield, Illinois 62704
Principal Investigator: John Sigle, DPM
?
mi
from
Springfield, IL
Click here to add this to my saved trials
State College, Pennsylvania 16801
Principal Investigator: Bradley Barter, DO
?
mi
from
State College, PA
Click here to add this to my saved trials
Tucson, Arizona 85723
Principal Investigator: Jodi Walters, DPM
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
Virginia Beach, Virginia 23464
Principal Investigator: Patrick S Agnew, DPM
Phone: 757-523-0414
?
mi
from
Virginia Beach, VA
Click here to add this to my saved trials