Description

This is a Phase 2b, double-blinded, randomised, placebo-controlled multicenter study to determine the safety and efficacy of TP-102, in patients with diabetic foot infection.Eighty (80) patients with an infected diabetic foot ulcer and with at least one target bacterial strain (Pseudomonas aeruginosa, Staphylococcus aureus or Acinetobacter baumannii) susceptible to TP-102.

Inclusion criteria

• Aged ≥18 years old.
• Established diagnosis of Diabetes Mellitus (type I or II).
• Designated foot infection meets the following criteria:
  • Present for at least 3 weeks.
  • Below-ankle, full-thickness, cutaneous ulcer.

Exclusion criteria

• Infected study ulcer less than 2 cm away from other ulcers, in the case of multiple ulcers.
• Patient receiving hyperbaric oxygen therapy (HBOT), negative pressure wound therapy (NPWT), bioengineering skin (BES) substitutes and/or growth factors.
• Patient which, in the opinion of the investigator, may not comply with study related procedures.
• Presence of active malignant or benign tumors of any kind, (with exception to nonmelanoma skin cancer as per investigator's discretion).
• Being pregnant or breastfeeding.

Clinical Trial Investigator

Dr. José David Suarez