Pilot Study of the Safety and Clinical Efficacy of Topical Dermacyn™ Wound Care to Treat Mild Diabetic Foot Infections

Completed · Phase 2

Conditions studied: Foot Ulcer, Diabetic

In brief

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.

Key facts

Study ID

NCT00516958

Run by

Oculus Innovative Sciences, Inc.

People needed

65

Starts

2007-05-01

Expected to finish

2007-12-01

Last updated by the study team

2008-01-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A patient must meet all of the following inclusion criteria to be enrolled in the study:
• Males and females > 18 years of age with diabetes mellitus (type 1 or type 2, controlled).
• Presence of infected, non-ischemic diabetic foot ulcer that involves skin and deeper soft tissue as stratified by IDSA guidelines and the UTC / 1B.
• Foot infections that are anticipated to be cured in 10 days of oral antibiotic therapy.
• Foot ulcers located in the plantar, dorsal or malleolar areas.
• Ulcers 1- 9 cm2 in size.
• An accessible infection site for culture.
• ABI by Doppler ≥ 0.8 or TcPO2 ≥ 30 mmHg.
• Palpable pulse on the study foot (either dorsalis or posterior tibial artery).
• Willing and able to give informed consent.
• Willing to comply with the requirements for participation in the study.

You may not qualify if…

• Patients are excluded if they meet any of the following criteria at the time of randomization:
• Previous antibiotic treatment received for more than 24 hours within 72 hours of study.
• Necrotizing fasciitis, deep abscesses in the soft tissue, sinus tracts, gas gangrene, or infected burns.
• Superinfected eczema or other chronic inflammatory skin conditions (i.e., atopic dermatitis).
• The patient´s ulcer is located on the stump of an amputated extremity.
• The patient's ulcer is due to a non-diabetic etiology.
• Infections complicated by the presence of prosthetic materials.
• Osteomyelitis
• Females of childbearing potential who are unable to take adequate contraceptive precautions or are breastfeeding.
• 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).
• Hypersensitivity to chlorine or quinolones.
• Need for any additional concomitant systemic antibacterial agent other than the study drug(s).
• Concomitant glucocorticoid doses (> 5mg prednisone a day or equivalent).
• Adjuvant therapy with hyperbaric oxygen or topical formulations containing growth factors, antimicrobials or enzymatic debriders.
• A history of diseases of immune function (HIV, chronic granulomatous disease).
• Any medical condition that, in the investigator´s opinion, will require dose modification of Levofloxacin to less than 750 mg a day.
• Has received an investigational agent ≤1 month prior to the baseline evaluation.

Where it is running

• Study site — Tucson, Arizona, United States
• Study site — La Jolla, California, United States
• Study site — Los Angeles, California, United States
• Study site — San Diego, California, United States
• Study site — Santa Rosa, California, United States
• Study site — Denver, Colorado, United States
• Study site — New Haven, Connecticut, United States
• Study site — Boca Raton, Florida, United States
• Study site — Spring Hill, Florida, United States
• Study site — Evansville, Indiana, United States
• Study site — Louisville, Kentucky, United States
• Study site — Boston, Massachusetts, United States
• Study site — Harrisburgh, Pennsylvania, United States
• Study site — Hazleton, Pennsylvania, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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