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

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetic Foot Infection

In brief

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.

Key facts

Study ID

NCT01594762

Run by

Dipexium Pharmaceuticals, Inc.

People needed

200

Starts

2014-06-01

Expected to finish

2016-07-01

Last updated by the study team

2017-06-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diabetes mellitus.
• Male or female at least 18 years old.
• 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.
• Subject is to be treated on an outpatient basis.
• 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.
• Localized mild infection of the ulcer.
• The diagnosis of mild infection must be confirmed immediately following debridement at Baseline.
• 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.

You may not qualify if…

• IDSA-defined moderate infection, including cellulitis extending > 2 cm; lymphangitis; spread beneath the fascia; deep tissue abscess; gangrene; muscle, joint, or bone involvement.
• IDSA-defined severe infection, including systemic toxicity or metabolic instability.
• Infected diabetic foot ulcer that is associated with local wound complications such as prosthetic materials or protruding surgical hardware.
• > 1 infected foot ulcer.
• Subject is currently receiving topical antimicrobial treatment for a localized infection of the study ulcer and whose infection is improving in response to treatment.
• Subject has received a systemic antibiotic within 48 hours prior to Screening.
• Concurrent or expected to require systemic antimicrobials during the study period for any infection, including diabetic foot ulcer.
• Bone or joint involvement is suspected based on clinical examination or plain X-ray.
• Clinically significant peripheral arterial disease requiring vascular intervention.
• 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.

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Jonesboro, Arkansas, United States
• Study site — Castro Valley, California, United States
• Study site — Davis, California, United States
• Study site — Los Angeles, California, United States
• Study site — Napa, California, United States
• Study site — San Francisco, California, United States
• Study site — Santa Rosa, California, United States
• Study site — Sylmar, California, United States
• Study site — Vacaville, California, United States
• Study site — Norwalk, Connecticut, United States
• Study site — Coral Gables, Florida, United States
• Study site — Doral, Florida, United States
• Study site — Hialeah, Florida, United States
• Study site — Homestead, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Largo, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Miami Lakes, Florida, United States
• Study site — Miami Shores, Florida, United States
• Study site — Pinellas Park, Florida, United States
• Study site — Evans, Georgia, United States
• Study site — North Chicago, Illinois, United States
• Study site — Hutchinson, Kansas, United States

Full record on ClinicalTrials.gov

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