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

NCT00516958 | Completed Phase 2

• 1 other identifier: OIS-005
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 16

Brief 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.

Conditions

Foot Ulcer, Diabetic

Keywords

diabetic; ulcer; infection; topical; wound

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• 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)

Study Arms (3)

1

EXPERIMENTAL

Topical Dermacyn

Drug: Topical Dermacyn

2

ACTIVE COMPARATOR

Topical Dermacyn and levofloxacin

Drug: Topical Dermacyn and Levofloxacin

3

ACTIVE COMPARATOR

Topical saline and levofloxacin

Drug: Topical Saline and Levofloxacin

Interventions

Topical Dermacyn DRUG

Topical Dermacyn once a day for 10 Days

Also known as: Dermacyn™ Wound Care

1

Topical Dermacyn and Levofloxacin DRUG

Topical Dermacyn once a day and levofloxacin 750 mg PO per day; both for 10 days

Also known as: Dermacyn™ Wound Care, Levaquin®

2

Topical Saline and Levofloxacin DRUG

Topical saline once a day and levofloxacin 750 mg PO daily, both for 10 days

Also known as: Saline Solution, Levoquin®

3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

Sponsors & Collaborators

• Oculus Innovative Sciences, Inc.: lead

Study Sites (16)

Unknown Facility

Tucson, Arizona, 85710, United States

Location

Unknown Facility

La Jolla, California, 92037, United States

Location

Unknown Facility

Los Angeles, California, 90063-2326, United States

Location

Unknown Facility

San Diego, California, 92103-8896, United States

Location

Unknown Facility

Santa Rosa, California, 34669, United States

Location

Unknown Facility

Denver, Colorado, 80220, United States

Location

Unknown Facility

New Haven, Connecticut, 06515, United States

Location

Unknown Facility

Boca Raton, Florida, 33486, United States

Location

Unknown Facility

Spring Hill, Florida, 34609, United States

Location

Unknown Facility

Evansville, Indiana, 47714, United States

Location

Unknown Facility

Louisville, Kentucky, 40222, United States

Location

Unknown Facility

Boston, Massachusetts, 02215, United States

Location

Unknown Facility

Harrisburgh, Pennsylvania, 17112, United States

Location

Unknown Facility

Hazleton, Pennsylvania, 18201, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, 15224, United States

Location

Unknown Facility

Salt Lake City, Utah, 54102, United States

Location

Related Publications (5)

• 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.

  PMID: 17344198 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.

  PMID: 16242210 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.

  PMID: 17553033 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.

  PMID: 17570318 BACKGROUND

• Zahumensky E. [Infections and diabetic foot syndrome in field practice]. Vnitr Lek. 2006 May;52(5):411-6. Czech.

  PMID: 16771079 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot; Ulcer; Infections; Wounds and Injuries

Interventions

dermacyn; Levofloxacin; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Andres Gutierrez, M.D., Ph.D.

  Oculus Innovative Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 14, 2007
• First Posted: August 16, 2007
• Study Start: May 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: January 14, 2008

Record last verified: 2008-01

Locations

US (16)