Clinical trial NCT00516958: Pilot Study of the Safety and Clinical Efficacy of Topical Dermacyn™ Wound Care to Treat Mild Diabetic Foot Infections
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Foot Ulcer, Diabetic
Keywords: diabetic
ulcer
infection
topical
wound
Lead sponsor: Oculus Innovative Sciences, Inc.
Sponsor class: INDUSTRY
First posted: 2007-08-16
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: Visit 3 (Day 10); Visit 4 (Day 24)
Secondary outcomes:
measure: To compare the treatment groups with respect to microbiological outcome. Incidence of adverse events and other safety outcomes
timeFrame: Visit 2 (Day 3); Visit 3 (Day 10)
Other outcomes:
Locations:
city: Tucson
country: United States
state: Arizona
city: La Jolla
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: San Diego
country: United States
state: California
city: Santa Rosa
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: New Haven
country: United States
state: Connecticut
city: Boca Raton
country: United States
state: Florida
city: Spring Hill
country: United States
state: Florida
city: Evansville
country: United States
state: Indiana
city: Louisville
country: United States
state: Kentucky
city: Boston
country: United States
state: Massachusetts
city: Harrisburgh
country: United States
state: Pennsylvania
city: Hazleton
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Salt Lake City
country: United States
state: Utah
Study officials:
affiliation: Oculus Innovative Sciences
name: Andres Gutierrez, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Zahumensky E. [Infections and diabetic foot syndrome in field practice]. Vnitr Lek. 2006 May;52(5):411-6. Czech.