Pexiganan Versus Placebo Control for the Treatment of Mild Infections of Diabetic Foot Ulcers

Diabetic Foot Infection Clinical Trial

— OneStep-2  

Official title:

A Randomized, Double-Blind, Multicenter, Superiority, Placebo-Controlled Phase 3 Study of Pexiganan Cream 0.8% Applied Twice Daily for 14 Days in the Treatment of Adults With Mild Infections of Diabetic Foot Ulcers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01594762
• Other study ID #: DPX-306
• Status: Completed
• Phase: Phase 3
• First received: May 7, 2012
• Last updated: April 10, 2017
• Start date: June 2014
• Est. completion date: July 2016

Study information

• Verified date: April 2017
• Source: Dipexium Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to establish the clinical superiority and the safety of topical pexiganan cream 0.8% plus standard local wound care as compared to placebo cream plus standard local wound care, in the treatment of mildly infected diabetic foot ulcers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Diabetes mellitus.

2. Male or female at least 18 years old.

3. Subject must agree to adhere to all protocol procedures and return for all scheduled visits, and must be willing and able to provide written informed consent.

4. Subject is to be treated on an outpatient basis.

5. Full thickness ulcer or a partial thickness ulcer on the foot distal to the malleoli with a surface area = 1 cm2 after the wound has undergone appropriate debridement.

6. Localized mild infection of the ulcer.

7. The diagnosis of mild infection must be confirmed immediately following debridement at Baseline.

8. Subject must have plain radiographs taken within 2 days prior to entry showing no evidence of bony abnormalities consistent with osteomyelitis, or gas compatible with tissue crepitus, in the affected foot.

Exclusion Criteria:

1. IDSA-defined moderate infection, including cellulitis extending > 2 cm; lymphangitis; spread beneath the fascia; deep tissue abscess; gangrene; muscle, joint, or bone involvement.

2. IDSA-defined severe infection, including systemic toxicity or metabolic instability.

3. Infected diabetic foot ulcer that is associated with local wound complications such as prosthetic materials or protruding surgical hardware.

4. > 1 infected foot ulcer.

5. Subject is currently receiving topical antimicrobial treatment for a localized infection of the study ulcer and whose infection is improving in response to treatment.

6. Subject has received a systemic antibiotic within 48 hours prior to Screening.

7. Concurrent or expected to require systemic antimicrobials during the study period for any infection, including diabetic foot ulcer.

8. Bone or joint involvement is suspected based on clinical examination or plain X-ray.

9. Clinically significant peripheral arterial disease requiring vascular intervention.

10. Subject is expected to be unable to care for the ulcer or return for all scheduled visits because of hospitalization, vacation, disability, etc. during the study period, or is unable to safely monitor the infection status at home.

Related Conditions & MeSH terms

• Communicable Diseases
• Diabetic Foot
• Diabetic Foot Infection
• Foot Ulcer
• Infection

Intervention

Drug:
• Topical pexiganan cream 0.8%
14 days of treatment
• Topical placebo cream
14 days of treatment

Other:
• Standard wound care
14 days of treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dipexium Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Response	Clinical Response will be classified according to the Investigator's medical judgment as one of the following: infection resolved, infection not resolved, recurrent infection, or unevaluable.	28 days
Secondary	Microbiological Response	Microbiological Response to therapy will be categorized as one of the following: complete microbiological response, partial microbiological response, no microbiological response, colonization, superinfection, relapse, reinfection, unevaluable or not applicable.	28 days
Secondary	Incidence and severity of adverse events		28 days