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

Phase 2

Completed

• Conditions: Foot Ulcer, Diabetic
• Interventions: Drug: Topical Saline and Levofloxacin; Drug: Topical Dermacyn; Drug: Topical Dermacyn and Levofloxacin

• Registration Number: NCT00516958
• Lead Sponsor: Oculus Innovative Sciences, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-08-14
• Study First Submitted QC: 2007-08-14
• Study First Posted: 2007-08-16
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2008-01
• Last Update Submitted: 2008-01-07
• Last Update Posted: 2008-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	Topical Saline and Levofloxacin	Topical saline and levofloxacin
1	Topical Dermacyn	Topical Dermacyn
2	Topical Dermacyn and Levofloxacin	Topical Dermacyn and levofloxacin

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)