Pilot Study of the Safety and Clinical Efficacy of Topical Dermacyn™ Wound Care to Treat Mild Diabetic Foot Infections
NCT ID: NCT00516958
Last Updated: 2008-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
65 participants
INTERVENTIONAL
2007-05-31
2007-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Topical Dermacyn
Topical Dermacyn
Topical Dermacyn once a day for 10 Days
2
Topical Dermacyn and levofloxacin
Topical Dermacyn and Levofloxacin
Topical Dermacyn once a day and levofloxacin 750 mg PO per day; both for 10 days
3
Topical saline and levofloxacin
Topical Saline and Levofloxacin
Topical saline once a day and levofloxacin 750 mg PO daily, both for 10 days
Interventions
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Topical Dermacyn
Topical Dermacyn once a day for 10 Days
Topical Dermacyn and Levofloxacin
Topical Dermacyn once a day and levofloxacin 750 mg PO per day; both for 10 days
Topical Saline and Levofloxacin
Topical saline once a day and levofloxacin 750 mg PO daily, both for 10 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Presence of infected, non-ischemic diabetic foot ulcer that involves skin and deeper soft tissue as stratified by IDSA guidelines and the UTC / 1B.
3. Foot infections that are anticipated to be cured in 10 days of oral antibiotic therapy.
4. Foot ulcers located in the plantar, dorsal or malleolar areas.
5. Ulcers 1- 9 cm2 in size.
6. An accessible infection site for culture.
7. ABI by Doppler ≥ 0.8 or TcPO2 ≥ 30 mmHg.
8. Palpable pulse on the study foot (either dorsalis or posterior tibial artery).
9. Willing and able to give informed consent.
10. Willing to comply with the requirements for participation in the study.
Exclusion Criteria
1. Previous antibiotic treatment received for more than 24 hours within 72 hours of study.
2. Necrotizing fasciitis, deep abscesses in the soft tissue, sinus tracts, gas gangrene, or infected burns.
3. Superinfected eczema or other chronic inflammatory skin conditions (i.e., atopic dermatitis).
4. The patient´s ulcer is located on the stump of an amputated extremity.
5. The patient's ulcer is due to a non-diabetic etiology.
6. Infections complicated by the presence of prosthetic materials.
7. Osteomyelitis
8. Females of childbearing potential who are unable to take adequate contraceptive precautions or are breastfeeding.
9. Known to have liver disease, with total bilirubin \> 5 times the Upper Limit of Normal (ULN); known to have neutropenia (absolute neutrophil count \<500 cells/mm3).
10. Hypersensitivity to chlorine or quinolones.
11. Need for any additional concomitant systemic antibacterial agent other than the study drug(s).
12. Concomitant glucocorticoid doses (\> 5mg prednisone a day or equivalent).
13. Adjuvant therapy with hyperbaric oxygen or topical formulations containing growth factors, antimicrobials or enzymatic debriders.
14. A history of diseases of immune function (HIV, chronic granulomatous disease).
15. Any medical condition that, in the investigator´s opinion, will require dose modification of Levofloxacin to less than 750 mg a day.
16. Has received an investigational agent ≤1 month prior to the baseline evaluation.
18 Years
ALL
No
Sponsors
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Oculus Innovative Sciences, Inc.
INDUSTRY
Responsible Party
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Oculus Innovative Sciences, Inc.
Principal Investigators
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Andres Gutierrez, M.D., Ph.D.
Role: STUDY_DIRECTOR
Oculus Innovative Sciences
Locations
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Tucson, Arizona, United States
La Jolla, California, United States
Los Angeles, California, United States
San Diego, California, United States
Santa Rosa, California, United States
Denver, Colorado, United States
New Haven, Connecticut, United States
Boca Raton, Florida, United States
Spring Hill, Florida, United States
Evansville, Indiana, United States
Louisville, Kentucky, United States
Boston, Massachusetts, United States
Harrisburgh, Pennsylvania, United States
Hazleton, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Salt Lake City, Utah, United States
Countries
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References
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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.
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.
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.
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.
Zahumensky E. [Infections and diabetic foot syndrome in field practice]. Vnitr Lek. 2006 May;52(5):411-6. Czech.
Other Identifiers
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OIS-005
Identifier Type: -
Identifier Source: org_study_id
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