A Study to Investigate the Safety and Clinical Effect of Nexagon® as a Topical Treatment for Subjects With a Diabetic Foot Ulcer (DUNE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CoDa Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT01490879
First received: December 11, 2011
Last updated: April 29, 2014
Last verified: April 2014
  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.


Condition Intervention Phase
Diabetic Foot Ulcers
Drug: Nexagon® Low Dose
Drug: Nexagon® Medium Dose
Drug: Nexagon® High Dose
Drug: Nexagon® vehicle
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by CoDa Therapeutics Inc.:

Primary Outcome Measures:
  • Incidence of Reference Diabetic Foot Ulcer (RDFU) complete closure determined by Investigator Assessment [ Time Frame: Within 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage change in RDFU surface area [ Time Frame: Within 12 weeks ] [ Designated as safety issue: No ]
  • Time to RDFU complete closure [ Time Frame: Within 12 weeks ] [ Designated as safety issue: No ]
  • Percentage of granulation tissue in RDFU [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Incidence of ulcer recurrence [ Time Frame: 12 weeks post-closure ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 168
Study Start Date: July 2012
Study Completion Date: April 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nexagon® Low Dose
Twice weekly applications of Nexagon® low dose in addition to off-loading using a Removable Cast Walker
Drug: Nexagon® Low Dose
Twice weekly, topical application of Nexagon® low dose in addition to a Removable Cast Walker
Experimental: Nexagon® Medium Dose
Twice weekly applications of Nexagon® medium dose in addition to off-loading using a Removable Cast Walker
Drug: Nexagon® Medium Dose
Twice weekly, topical application of Nexagon® medium dose in addition to a Removable Cast Walker
Experimental: Nexagon® High Dose
Twice weekly applications of Nexagon® high dose in addition to off-loading using a Removable Cast Walker
Drug: Nexagon® High Dose
Twice weekly, topical application of Nexagon® high dose in addition to a Removable Cast Walker
Placebo Comparator: Nexagon® vehicle
Twice weekly applications of Nexagon® vehicle in addition to off-loading using a Removable Cast Walker
Drug: Nexagon® vehicle
Twice weekly, topical application of Nexagon® vehicle in addition to a Removable Cast Walker

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

5. 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).

6. 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.

11. Subjects presenting with the clinical characteristics of cellulitis at the ulcer site. 12. 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.

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

16. 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.

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

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

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

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

21. 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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01490879

Locations
United States, Arizona
Associated Foot and Ankle Specialists, LLC
Phoenix, Arizona, United States, 85015
University of Arizona Medical Center
Tucson, Arizona, United States, 85724
United States, California
Center For Clinical Research Inc.
Castro Valley, California, United States, 94546
Advanced Foot Care and Clinical Research Center
Fresno, California, United States, 93722
United States, Florida
Barry University Clinical Research
Hialeah, Florida, United States, 33013
Univeristy of Miami, Miller School of Medicine, Dermatology Research
Miami, Florida, United States, 33136
Doctors Research Network
South Miami, Florida, United States, 33143
United States, Nevada
Advanced Foot and Ankle Center
Las Vegas, Nevada, United States, 89119
United States, Texas
Houston Foot and Ankle Care
Houston, Texas, United States, 77074
Russian Federation
Kemerovo Regional Clinical Hospital
Kemerovo, Russian Federation, 650066
Endocrinology Science Center
Moscow, Russian Federation, 117036
Federal bureau of medical and social expertise, Moscow
Moscow, Russian Federation, 127486
City Clinical Hospital #13
Moscow, Russian Federation, 1154280
Endocrinology Clinic of Moscow, Department of Healthcare
Moscow, Russian Federation, 119034
Moscow Medical University n.a.
Moscow, Russian Federation, 119435
St Petersburg Diagnostic Center
St Petersburg, Russian Federation, 198255
St Petersburg City Hospital of St Elizabeth
St Petersburg, Russian Federation, 198099
Voronezh Regional Clinical Consultative Diagnostic Center
Voronezh, Russian Federation
Ukraine
Cherkasy Regional Clinical Hospital, Endocrinology Department
Cherkasy, Ukraine, 18009
Dnipropetrovsk Regional Clinical Hospitaln. a. I.I. Mechnikov
Dnipropetrovsk, Ukraine, 49005
Ivano-Frankivsk Central City Clinical Hospital
Ivano-Frankivsk, Ukraine, 76025
Regional Clinical Hospital, Cardiovascular Surgery Department
Kharkiv, Ukraine, 61022
Kyiv City Clinical Hospital #1
Kyiv, Ukraine, 02091
Institute of Endocrinology and Methabolism n.a. V.P. Komisarenko, Clinical Diabetology Department
Kyiv, Ukraine, 04114
Zaporizhzhya City Clinical Hospital #9
Zaporizhzhya, Ukraine, 69096
Sponsors and Collaborators
CoDa Therapeutics Inc.
Investigators
Principal Investigator: David G Armstrong, DPM MD PhD S.A.L.S.A. , University of Arizona, Tucson, AZ
  More Information

No publications provided

Responsible Party: CoDa Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT01490879     History of Changes
Other Study ID Numbers: NEX-ULC-011
Study First Received: December 11, 2011
Last Updated: April 29, 2014
Health Authority: United States: Food and Drug Administration
Russia: Ministry of Health
Ukraine: Ministry of Health

Keywords provided by CoDa Therapeutics Inc.:
DFU
Diabetic Foot Ulcer
Ulcers
Foot Ulcers
chronic wound
wounds
Nexagon
CoDa

Additional relevant MeSH terms:
Ulcer
Foot Ulcer
Diabetic Foot
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on July 28, 2014