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

Oculus Innovative Sciences

Status and phase: Completed; Phase 2

Conditions: Foot Ulcer, Diabetic

Treatments: Drug: Topical Dermacyn and Levofloxacin; Drug: Topical Dermacyn; Drug: Topical Saline and Levofloxacin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00516958

OIS-005

Details and patient eligibility

About

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.

Enrollment: 65 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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65 participants in 3 patient groups

1

Experimental group

Description:

Topical Dermacyn

Treatment:

Drug: Topical Dermacyn

2

Active Comparator group

Description:

Topical Dermacyn and levofloxacin

Treatment:

Drug: Topical Dermacyn and Levofloxacin

3

Active Comparator group

Description:

Topical saline and levofloxacin

Treatment:

Drug: Topical Saline and Levofloxacin