Pilot Study of the Safety and Clinical Efficacy of Topical Dermacyn™ Wound Care to Treat Mild Diabetic Foot Infections
Information source: Oculus Innovative Sciences, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Foot Ulcer, Diabetic
Intervention: Topical Dermacyn (Drug); Topical Dermacyn and Levofloxacin (Drug); Topical Saline and Levofloxacin (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Oculus Innovative Sciences, Inc. Official(s) and/or principal investigator(s):
Andres Gutierrez, M.D., Ph.D., Study Director, Affiliation: Oculus Innovative Sciences
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.
Clinical Details
Official title: An Open Label, Three Arm, Pilot Study of the Safety and Clinical Efficacy of Topical Dermacyn™ Wound Care vs. Oral Levofloxacin vs. Combined Therapy for Mild Diabetic Foot Infections
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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
Secondary outcome: To compare the treatment groups with respect to microbiological outcome.
Incidence of adverse events and other safety outcomes
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- A patient must meet all of the following inclusion criteria to be enrolled in the
study:
1. Males and females > 18 years of age with diabetes mellitus (type 1 or type 2,
controlled).
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:
Patients are excluded if they meet any of the following criteria at the time of
randomization:
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.
Locations and Contacts
Tucson, Arizona 85710, United States
Santa Rosa, California 34669, United States
Los Angeles, California 90063-2326, United States
San Diego, California 92103-8896, United States
La Jolla, California 92037, United States
Denver, Colorado 80220, United States
New Haven, Connecticut 06515, United States
Spring Hill, Florida 34609, United States
Boca Raton, Florida 33486, United States
Evansville, Indiana 47714, United States
Louisville, Kentucky 40222, United States
Boston, Massachusetts 02215, United States
Harrisburgh, Pennsylvania 17112, United States
Pittsburgh, Pennsylvania 15224, United States
Hazleton, Pennsylvania 18201, United States
Salt Lake City, Utah 54102, United States
Additional Information
Related publications: 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. 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. Epub 2005 Oct 19. Duc Q, 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. 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. Epub 2007 Apr 16. Zahumensky E. [Infections and diabetic foot syndrome in field practice] Vnitr Lek. 2006 May;52(5):411-6. Review. Czech.
Starting date: May 2007
Ending date: December 2007
Last updated: January 7, 2008
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