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To compare the rates of clinical success of Topical Dermacyn™ vs. Oral Levofloxacin vs. Combined therapy, in subjects with mild diabetic foot infections in non-ischemic ulcers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Topical Dermacyn |
|
| 2 | Active Comparator | Topical Dermacyn and levofloxacin |
|
| 3 | Active Comparator | Topical saline and levofloxacin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical Dermacyn | Drug | Topical Dermacyn once a day for 10 Days |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| To compare the rates of clinical success (cure + improvement) of Topical Dermacyn™ vs. Oral Levofloxacin vs. Combined therapy, in patients with mild diabetic foot infections in non ischemic ulcers | Visit 3 (Day 10); Visit 4 (Day 24) |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the treatment groups with respect to microbiological outcome. Incidence of adverse events and other safety outcomes | Visit 2 (Day 3); Visit 3 (Day 10) |
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Inclusion Criteria:
A patient must meet all of the following inclusion criteria to be enrolled in the study:
Exclusion Criteria:
Patients are excluded if they meet any of the following criteria at the time of randomization:
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| Name | Affiliation | Role |
|---|---|---|
| Andres Gutierrez, M.D., Ph.D. | Oculus Innovative Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tucson | Arizona | 85710 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17344198 | Background | Goretti C, Mazzurco S, Nobili LA, Macchiarini S, Tedeschi A, Palumbo F, Scatena A, Rizzo L, Piaggesi A. Clinical outcomes of wide postsurgical lesions in the infected diabetic foot managed with 2 different local treatment regimes compared using a quasi-experimental study design: a preliminary communication. Int J Low Extrem Wounds. 2007 Mar;6(1):22-7. doi: 10.1177/1534734606298543. | |
| 16242210 |
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| Topical Dermacyn and Levofloxacin | Drug | Topical Dermacyn once a day and levofloxacin 750 mg PO per day; both for 10 days |
|
|
| Topical Saline and Levofloxacin | Drug | Topical saline once a day and levofloxacin 750 mg PO daily, both for 10 days |
|
|
| La Jolla |
| California |
| 92037 |
| United States |
| Los Angeles | California | 90063-2326 | United States |
| San Diego | California | 92103-8896 | United States |
| Santa Rosa | California | 34669 | United States |
| Denver | Colorado | 80220 | United States |
| New Haven | Connecticut | 06515 | United States |
| Boca Raton | Florida | 33486 | United States |
| Spring Hill | Florida | 34609 | United States |
| Evansville | Indiana | 47714 | United States |
| Louisville | Kentucky | 40222 | United States |
| Boston | Massachusetts | 02215 | United States |
| Harrisburgh | Pennsylvania | 17112 | United States |
| Hazleton | Pennsylvania | 18201 | United States |
| Pittsburgh | Pennsylvania | 15224 | United States |
| Salt Lake City | Utah | 54102 | United States |
| Background |
| Landa-Solis C, Gonzalez-Espinosa D, Guzman-Soriano B, Snyder M, Reyes-Teran G, Torres K, Gutierrez AA. Microcyn: a novel super-oxidized water with neutral pH and disinfectant activity. J Hosp Infect. 2005 Dec;61(4):291-9. doi: 10.1016/j.jhin.2005.04.021. Epub 2005 Oct 19. |
| 17553033 | Background | Duc Ql, Breetveld M, Middelkoop E, Scheper RJ, Ulrich MM, Gibbs S. A cytotoxic analysis of antiseptic medication on skin substitutes and autograft. Br J Dermatol. 2007 Jul;157(1):33-40. doi: 10.1111/j.1365-2133.2007.07990.x. Epub 2007 Jun 6. |
| 17570318 | Background | Medina-Tamayo J, Sanchez-Miranda E, Balleza-Tapia H, Ambriz X, Cid ME, Gonzalez-Espinosa D, Gutierrez AA, Gonzalez-Espinosa C. Super-oxidized solution inhibits IgE-antigen-induced degranulation and cytokine release in mast cells. Int Immunopharmacol. 2007 Aug;7(8):1013-24. doi: 10.1016/j.intimp.2007.03.005. Epub 2007 Apr 16. |
| 16771079 | Background | Zahumensky E. [Infections and diabetic foot syndrome in field practice]. Vnitr Lek. 2006 May;52(5):411-6. Czech. |
| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D014456 | Ulcer |
| D007239 | Infections |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| 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 |
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| ID | Term |
|---|---|
| C554598 | dermacyn |
| D064704 | Levofloxacin |
| D012965 | Sodium Chloride |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D015242 | Ofloxacin |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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