Glycophosphopeptical as adjuvant treatment of diabetic foot injury: a pilot study.
BACKGROUND
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.


METHODS
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.


RESULTS
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 <0.05). There were 13 amputations in the study group vs. 17 in the control group. In the group treated with glycophosphopeptical, there were 15 patient who were healed or improved and four failures vs. seven patients in the control group who were healed or improved and 12 failures. There were only four failures in the study group vs. seven in the control group with 12 failures (p = 0.03). TNF-α was lower in the study group than in the control group (p <0.02).


CONCLUSIONS
Glycophosphopeptical is useful as adjuvant therapy in diabetic foot injuries.
Servicio de Angiología, Hospital Regional Dr. Valentín Gómez Farías ISSSTE, Guadalajara, Jalisco. México.
Héctor
H
Ruiz-Mercado
Miguel
M
Huerta-Viera
Rafael
R
Bustos-Saldaña
Ernesto
E
Sahagún-Flores
Georgina
G
Hernández-Flores
Alejandro
A
Bravo-Cuellar
D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D002130:Calcium Phosphates / Q000627:therapeutic use*; D017719:Diabetic Foot / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006020:Glycopeptides / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies
D000276:Adjuvants, Immunologic; D002130:Calcium Phosphates; D006020:Glycopeptides; C038773:Immunoferon