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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nexagon® Low Dose | Experimental | Twice weekly applications of Nexagon® low dose in addition to off-loading using a Removable Cast Walker |
|
| Nexagon® Medium Dose | Experimental | Twice weekly applications of Nexagon® medium dose in addition to off-loading using a Removable Cast Walker |
|
| Nexagon® High Dose | Experimental | Twice weekly applications of Nexagon® high dose in addition to off-loading using a Removable Cast Walker |
|
| Nexagon® vehicle | Placebo Comparator | Twice weekly applications of Nexagon® vehicle in addition to off-loading using a Removable Cast Walker |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nexagon® Low Dose | Drug | Twice weekly, topical application of Nexagon® low dose in addition to a Removable Cast Walker |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Reference Diabetic Foot Ulcer (RDFU) complete closure determined by Investigator Assessment | Within 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in RDFU surface area | Within 12 weeks | |
| Time to RDFU complete closure | Within 12 weeks | |
| Percentage of granulation tissue in RDFU |
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Inclusion Criteria:
Exclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| David G Armstrong, DPM MD PhD | S.A.L.S.A. , University of Arizona, Tucson, AZ | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Associated Foot and Ankle Specialists, LLC | Phoenix | Arizona | 85015 | United States | ||
| University of Arizona Medical Center |
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| Nexagon® Medium Dose | Drug | Twice weekly, topical application of Nexagon® medium dose in addition to a Removable Cast Walker |
|
| Nexagon® High Dose | Drug | Twice weekly, topical application of Nexagon® high dose in addition to a Removable Cast Walker |
|
| Nexagon® vehicle | Drug | Twice weekly, topical application of Nexagon® vehicle in addition to a Removable Cast Walker |
|
| 12 weeks |
| Incidence of ulcer recurrence | 12 weeks post-closure |
| Incidence of adverse events | 12 weeks |
| Tucson |
| Arizona |
| 85724 |
| United States |
| Center For Clinical Research Inc. | Castro Valley | California | 94546 | United States |
| Advanced Foot Care and Clinical Research Center | Fresno | California | 93722 | United States |
| Barry University Clinical Research | Hialeah | Florida | 33013 | United States |
| Univeristy of Miami, Miller School of Medicine, Dermatology Research | Miami | Florida | 33136 | United States |
| Doctors Research Network | South Miami | Florida | 33143 | United States |
| Advanced Foot and Ankle Center | Las Vegas | Nevada | 89119 | United States |
| Houston Foot and Ankle Care | Houston | Texas | 77074 | United States |
| Kemerovo Regional Clinical Hospital | Kemerovo | 650066 | Russia |
| City Clinical Hospital #13 | Moscow | 1154280 | Russia |
| Endocrinology Science Center | Moscow | 117036 | Russia |
| Endocrinology Clinic of Moscow, Department of Healthcare | Moscow | 119034 | Russia |
| Moscow Medical University n.a. | Moscow | 119435 | Russia |
| Federal bureau of medical and social expertise, Moscow | Moscow | 127486 | Russia |
| St Petersburg City Hospital of St Elizabeth | Saint Petersburg | 198099 | Russia |
| St Petersburg Diagnostic Center | Saint Petersburg | 198255 | Russia |
| Voronezh Regional Clinical Consultative Diagnostic Center | Voronezh | Russia |
| Cherkasy Regional Clinical Hospital, Endocrinology Department | Cherkasy | 18009 | Ukraine |
| Dnipropetrovsk Regional Clinical Hospitaln. a. I.I. Mechnikov | Dnipropetrovsk | 49005 | Ukraine |
| Ivano-Frankivsk Central City Clinical Hospital | Ivano-Frankivsk | 76025 | Ukraine |
| Regional Clinical Hospital, Cardiovascular Surgery Department | Kharkiv | 61022 | Ukraine |
| Kyiv City Clinical Hospital #1 | Kyiv | 02091 | Ukraine |
| Institute of Endocrinology and Methabolism n.a. V.P. Komisarenko, Clinical Diabetology Department | Kyiv | 04114 | Ukraine |
| Zaporizhzhya City Clinical Hospital #9 | Zaporizhzhya | 69096 | Ukraine |
| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D014456 | Ulcer |
| D016523 | Foot Ulcer |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005534 | Foot Diseases |
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