Due to the complexity of the diabetic foot, its high frequency of amputations and accompanying immunosuppression, treatment is difficult. We tested the usefulness of glycophosphopetical immunoregulator as adjuvant therapy for diabetic foot injury. We carried out a prospective double-blind randomized controlled study with 19 patients per group with diabetic foot injury III and IV (Wagner injury classification). The study group was treated orally with glycophosphopeptical (1 g/every 8 h for 4 weeks). Control group was treated with placebo. Both groups received conventional treatment: wound debridement, antibiotic therapy and metabolic control. Area and depth of injury was measured at the beginning of the study and after 2 months. Patients who were healed or showed improvement were quantified as well with serum levels of TNF-α, interferon-γ and IL-1β, 15 days after treatment initiation. The study group was comprised of 13 males and six females (mean age 61.6 ± 14.9 years) and the control group was comprised of five females and 14 males (mean age 56.7 ± 14.6 years). At the end of the study, the area and depth of the lesions were significantly lower in the study group (p