drugset / Trial / NCT00516958
Pilot Study of the Safety and Clinical Efficacy of Topical Dermacyn™ Wound Care to Treat Mild Diabetic Foot Infections
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2007-05
- Primary completion
- 2007-12
- Completion
- 2007-12
Publications
- 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.
- 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.
- 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.
- 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.
- Background Zahumensky E. [Infections and diabetic foot syndrome in field practice]. Vnitr Lek. 2006 May;52(5):411-6. Czech.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dermacyn | Unknown | — | Topical |
| Comparator | Levofloxacin | Small molecule | 750 mg | Oral |
| Subject | Topical Dermacyn | Unknown | — | Topical |