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

Foot Ulcer, Diabetic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00516958
• Other study ID #: OIS-005
• Status: Completed
• Phase: Phase 2
• First received: August 14, 2007
• Last updated: January 7, 2008
• Start date: May 2007
• Est. completion date: December 2007

Study information

• Verified date: January 2008
• Source: Oculus Innovative Sciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Foot
• Foot Ulcer, Diabetic

Intervention

Drug:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Oculus Innovative Sciences, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. Epub 2007 Jun 6. — View 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. — View Citation

Landa-Solis C, González-Espinosa D, Guzmán-Soriano B, Snyder M, Reyes-Terán 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. — View Citation

Medina-Tamayo J, Sánchez-Miranda E, Balleza-Tapia H, Ambriz X, Cid ME, González-Espinosa D, Gutiérrez AA, González-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. — View Citation

Záhumenský E. [Infections and diabetic foot syndrome in field practice]. Vnitr Lek. 2006 May;52(5):411-6. Review. Czech. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No