Skip Navigation

Advertise|Press|Contact|FAQ|CWConnect

Bookmark/Print/Share

Home » Clinical Trials » Diabetic Foot Ulcers

Clinical Trial Details

Overview

Research Study Summary

A clinical trial seeking patients for a research study for the treatment of Diabetic Foot Ulcers

Research Study Title

A Randomized, Prospective, Double-blind, Vehicle-controlled, Dose-ranging, Multi-center Study to Assess the Safety and Clinical Effect of Nexagon® in the Treatment of Subjects With a Diabetic Foot Ulcer

Purpose

This study is for Type I or Type II diabetic subjects with with a diabetic foot ulcer. The study is being done to determine if Nexagon® plus standard of care is more effective than placebo plus standard of care. Standard of care will include debridement of the ulcer, standardized dressings and standardized off-loading using a Removable Cast Walker.

To Learn more
Phase

2

Gender

Both Male and Female

Age

18 and up

Overall Status

Recruiting

Lead Sponsor

CoDa Therapeutics Inc.

Duration

12 Months

Facility Type

N/A

Eligibility

Both Male and Female ages 18 Years and up

Inclusion Criteria:

  1. Diagnosis of diabetes mellitus (Type I or II)

  2. HbA1c of less than or equal to 12.0%

  3. Diagnosis of neuropathic foot ulcer with partial or complete neuropathy

  4. Cutaneous ulcer on the plantar or dorsal aspect of the foot or toe that is greater or equal to 1.0cm2 and less than or equal to 8.0 cm2 in area at the end of the screening period and is full thickness with no exposed ligament, tendon, joint capsule or bone. Surface area will be measured by digital planimetry.

  5. The Medical Monitor(or delegate)must confirm that the reference diabetic foot ulcer (RDFU)is suitable for inclusion after reviewing digital photographs

  6. Wound bed consisting of completely viable tissue or one where completely viable tissue will be achieved by the end of the screening period.

  7. An Ankle Branchial Index (ABI) of greater or equal to 0.80 in concert with a bi- or tri-phasic Doppler flow pattern; or adequate circulation as demonstrated by any of the following methods: peri-wound transcutaneous partial pressure oxygen (TcpO2)greater or equal to 40 mmHg; or a toe pressure of greater or equal to 40 mmHg; or skin perfusion pressure of greater or equal to 40 mmHg.

  8. Ulcer present for 4 weeks or more or less than or equal to 12 months.

  9. Willing to wear a Removable Cast Walker (RCW) between study visits for the duration of the study.

  10. Signed informed consent form.

Exclusion Criteria:

  1. Any unstable medical condition that would cause the study to be detrimental to the subject.

  2. Decrease in RDFU size by more than 40% or increase in the ulcer size by more than 40% during the 14-day screening period as measured by digital planimetry.

  3. Ulcers caused primarily by untreated vascular insufficiency or ulcers with an etiology not related to diabetes.4. Ulcers above the ankle.

  4. Ulcers that cannot be effectively off-loaded using the cast walker and sole insert provided in this study (ulcers not located on the weight bearing surface of the foot do not require off-loading).

  5. Ulcers on the toes not accessible for photography (e.g. in the web space). 7. Presence of other ulcers within 2cm of the perimeter of the RDFU. 8. BMI > 45 9. Cannot tolerate or will not comply with the off-loading method, or non-compliance with standard or care.

10.The RDFU is infected (clinical assessment of infection)and/or biopsy proof of greater than 100,000 organisms per gram of tissue during the screening period.

  1. Subjects presenting with the clinical characteristics of cellulitis at the ulcer site.
  2. Necrosis, purulence, or sinus tracts that cannot be removed by debridement.13. Definite or suspected osteomyelitis within any wound located anywhere on the subjects body.14. Acute Charcot's neuroarthropathy as determined by clinical and/or previous radiographic examination.

  3. Severe Charcot deformity or rocker bottom foot with an associated plantar mid-foot or heel ulcer.

  4. Revascularization surgery on the leg with the wound to be treated less than or equal to 4 weeks prior to the start of the screening period.

  5. Requirement for concurrent topical antimicrobials to treat the RDFU after the end of the screening period.

  6. Received dermal substitute or living skin equivalent (e.g. Dermagraft® or Apligraf®) within 14 days prior of the start of the screening period.

  7. Severe complications of diabetes that in the opinion of the Investigator could interfere with wound healing or impede the subject's participation.

  8. Subjects on concurrent immunosuppressive therapy to include oral corticosteroid therapy equivalent to greater than 5 mg/day of prednisone.

  9. Any history of radiation therapy to the foot. 22. Female subjects who are pregnant or lactating. 23. Pre-menopausal women not using effective birth control methods as determined by the Investigator. 24. Life expectancy of < 12 months. 25. Subjects on renal replacement therapy. 26. Cancer within the last 3 years except basal and squamous cell carcinoma. 27. Cancer within the RDFU

Site Locations (23)

Country State City Zip Facility and Contact
United States Arizona Phoenix 85015 Associated Foot and Ankle Specialists, LLC
Norma Ramos
602-274-4100

Arthur Tallis, DPM
Principal Investigator
United States Arizona Tucson 85724 University of Arizona Medical Center
Marcy Watchman
502-237-8155

David Armstrong, DPM, MD, PhD
Principal Investigator
United States California Castro Valley 94546 Center For Clinical Research Inc.
Gayana Sarkisova
800-363-1069

Alexander Reyzelman, DPM
Principal Investigator
United States California Fresno 93722 Advanced Foot Care and Clinical Research Center
Jessica Jimenez
559-224-5101

Jay Mukker, DPM
Principal Investigator
United States Florida Hialeah 33013 Barry University Clinical Research
Maria Swartz
305-836-7550

Robert Snyder, DPM
Principal Investigator
United States Florida Miami 33136 Univeristy of Miami, Miller School of Medicine, Dermatology Research
Aliette Espinosa
305-689-3376

Robert Kirsner, MD
Principal Investigator
United States Florida South Miami 33143 Doctors Research Network
Maria Heimer
305-662-1444

Jason Hanft, DPM
Principal Investigator
United States Nevada Las Vegas 89119 Advanced Foot and Ankle Center
Joseph Dove
702-696-9552

Cyaandi Dove, DPM
Principal Investigator
United States Texas Houston 77074 Houston Foot and Ankle Care
Monica Vilchis
713-777-5343

Gabriel Maislos, MD
Principal Investigator
Russian Federation Kemerovo 650066 Kemerovo Regional Clinical Hospital
Dr. Olga Golinskaya
+7 951-178-28-23

Professor Liudmila Kvitkova
Principal Investigator
Russian Federation Moscow 117036 Endocrinology Science Center
Marianna Yaroslavceva
7 499 126 66 37

Professor Gagik Galstyan
Principal Investigator
Russian Federation Moscow 127486 Federal bureau of medical and social expertise, Moscow
Lubov Savchenko
+7(906)077-66-52

Irina Gurieva, Professor
Principal Investigator
Russian Federation Moscow 1154280 City Clinical Hospital #13
Dr.Elena Zakhovskaya
+7 495 674 36 46

Professor Grigory Rodoman
Principal Investigator
Russian Federation Moscow 119034 Endocrinology Clinic of Moscow, Department of Healthcare
Natalia Komelyagina
+7(903)711-16-38

Professor Mikhail Antsiferov
Principal Investigator
Russian Federation Moscow 119435 Moscow Medical University n.a.
Nadezhda Maximova
+7-926-697-85-43

Professor Maria Pavlova
Principal Investigator
Russian Federation St Petersburg 198255 St Petersburg Diagnostic Center
Alina Latcenko
+7 921 3581609

Olga Miroshnichenko
Principal Investigator
Russian Federation St Petersburg 198099 St Petersburg City Hospital of St Elizabeth
Tatiana Zelenina
+7 812 786 36 78

Professor Natalia Vorokhobina
Principal Investigator
Russian Federation Voronezh Voronezh Regional Clinical Consultative Diagnostic Center
Dr. Larisa Kolimbet
+79107449799

Dr Elena Zhdanova
Principal Investigator
Ukraine Dnipropetrovsk 49005 Dnipropetrovsk Regional Clinical Hospitaln. a. I.I. Mechnikov
Oksana Rylina
38 050 320 91 25

Sergiy Kosulnikov
Principal Investigator
Ukraine Kharkiv 61022 Regional Clinical Hospital, Cardiovascular Surgery Department
Igor Drozd
38 050 171 17 27

Iryna Lodyana
Principal Investigator
Ukraine Kyiv 02091 Kyiv City Clinical Hospital #1
Luchia Shchekaturova
38 067 777 44 57

Professor Oleksandr Larin
Principal Investigator
Ukraine Kyiv 04114 Institute of Endocrinology and Methabolism n.a. V.P. Komisarenko, Clinical Diabetology Department
Kateryna Ivaskiva
38 097 213 51 38

Valeria Orlenko
Principal Investigator
Ukraine Zaporizhzhya 69096 Zaporizhzhya City Clinical Hospital #9
Kateryna Petrova
38 050 420 45 49

Kostyantyn Mylytsya
Principal Investigator

Contact

Alexis White, BSc
+64 9 376 0420

If you would like to learn more about participating in this research study, please email the trial contact using the form below.

Name:
Address:
City:
State:
Zip/Postal Code:
Country:
Phone:
Email:  
Message:
 
Please leave this field empty.

NCT ID: NCT01490879

Date Last Changed: July 29, 2013

DISCLAIMER: This site is run by CenterWatch, a publishing company that focuses on the clinical trials industry. The information provided in this service is designed to help patients find clinical trials that may be of interest to them, and to help patients contact the centers conducting the research. CenterWatch is neither promoting this research nor involved in conducting any of these trials. Some study summaries have been edited for clarity purposes to make them easier to understand. View more study details here.