title: Clinical evaluation of De Marco formula as an adjunctive therapy for infected ischemic diabetic foot: a prospective randomized controlled trial.
abstract: BACKGROUND
  De Marco Formula (DMF) is a novel formulation of procaine and PVP.
  
  
  OBJECTIVE
  To assess the efficacy and safety of DMF as an adjunctive therapy for infected ischemic diabetic foot in a prospective randomized controlled clinical trial.
  
  
  METHODS
  Adult patients, 39 male/ 79 female, were randomly assigned (59 patients/treatment group) to the conventional therapy alone (A) or plus DMF (0, 15 ml/kg .day i.m.) during ten days and them twice a week until healing of the lesions or completion of 52 days (B).The response to the treatment was considered favorable when an amputation was not needed even though a decrease of the wound area or complete healing was not shown. It was considered unfavorable when a major amputation was necessary because of worsening of the lesion (wound spreading to any magnitude greater than the initial one) or the appearance of new wounds in the same leg.
  
  
  RESULTS
  Both groups were comparable with regard to age, sex, level of arterial occlusion, type of lesion, anatomic localization of lesions and previous surgical procedures. The cumulative percentage of unfavorable results was significantly lower after treatment B with respect to treatment A (25.4% vs. 45.8%; p= 0.02), for a reduction of 44.5%. Four slight adverse reactions were associated with DMF: vertigo and nausea at the 7th treatment administration (one patient), and headache and tachycardia at the 12th dose (another patient). Blood hemoglobin and leukocyte counts and serum alanine transaminase were not affected.
  
  
  CONCLUSIONS
  The treatment with DMF for 52 days as an adjuvant for the conventional therapy was associated with a lower need for major amputations. It was also well tolerated and safe.
authors: National Institute for Angiology and Vascular Surgery, Havana, Cuba.
authors: Héctor Alvarez
authors: HA
authors: Duarte
authors: José I
authors: JI
authors: Fernández Montequín
authors: Martha M
authors: MM
authors: Fors López
authors: José Hernández
authors: JH
authors: Carretero
authors: Miriam Mahia
authors: MM
authors: Vilas
authors: Milagros García
authors: MG
authors: Mesa
mesh_terms: D000368:Aged; D000671:Amputation, Surgical; D000779:Anesthetics, Local / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D017719:Diabetic Foot / Q000188:drug therapy* / Q000503:physiopathology; D004338:Drug Combinations; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007273:Injections, Intramuscular; D007511:Ischemia / Q000188:drug therapy / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D011205:Povidone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011343:Procaine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D016896:Treatment Outcome; D014945:Wound Healing / Q000187:drug effects; D014946:Wound Infection / Q000188:drug therapy
chemical_list: D000779:Anesthetics, Local; D004338:Drug Combinations; D011343:Procaine; D011205:Povidone