Tolerability and safety of conventional therapy combination with DeMarco formula for infected ischemic diabetic foot.
BACKGROUND
A study has found that major amputations are necessary on 69% of ischemic diabetic foot patients treated with conventional therapy. An uncontrolled study of 31 patients showed that only 33% needed major amputation after treatment with conventional therapy plus De Marco Formula (DMF), a novel formulation of procaine and Polyvinylpyrrolidone.


OBJECTIVE
To assess the tolerability and safety of the combination of conventional therapy and De Marco Formula for infected ischemic diabetic foot.


METHODS
Adult patients, 10 male/24 female, were treated with the conventional therapy for diabetic foot plus DMF (0.15 ml/kg/day IM) during ten days and then twice a week until healing of the lesions or completion of a 52-day period. Required amputations, lesion areas, adverse events occurrence and clinical laboratory parameters (hemoglobin, blood cell counts, glycosilated hemoglobin, total proteins, creatinine, alanine transaminase and alkaline phosphatase) were determined during the treatment period.


RESULTS
Two slight (5.88%) and one moderate (2.94%) adverse events (mainly cutaneous rash) were reported. The last one was reported on the 15th day of treatment and DMF dosing was discontinued by patient's request. Clinical laboratory mean values remained within normal ranges during treatment except for blood leukocyte counts that pathologically elevated at baseline and decreased to normality by treatment end. This study has found that 18.08% of patients (N=6) needed a lower limb amputation with the combined treatments. The standard reported rate in Cuba is 25-29%. Furthermore, a progressive reduction of the mean lesion area from 51.29 cm2 at the beginning to 1.89 cm2 at the end of the treatment (p=0.000001) was observed.


CONCLUSIONS
The treatment with De Marco Formula for 52 days as an adjuvant for the conventional therapy for infected ischemic diabetic foot was well tolerated and safe. These findings are consistent with those of a randomized prospective controlled study performed later.
Alvarez Duarte
Héctor
H
National Institute for Angiology and Vascular Surgery, Research Department, 1551 Calzada del Cerro, Postal code 12000, Havana City, Cuba. alduarte@infomed.sld.cu
Fors López
Martha M
MM
Carretero
José Hernández
JH
Vilas
Miriam Mahia
MM
García Mesa
Milagros
M
D000671:Amputation, Surgical; D000779:Anesthetics, Local / Q000008:administration & dosage / Q000009:adverse effects; D001424:Bacterial Infections / Q000188:drug therapy* / Q000601:surgery*; D003131:Combined Modality Therapy; D017719:Diabetic Foot / Q000188:drug therapy* / Q000601:surgery*; D004338:Drug Combinations; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011205:Povidone / Q000008:administration & dosage* / Q000009:adverse effects; D011343:Procaine / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
D000779:Anesthetics, Local; D004338:Drug Combinations; D011343:Procaine; D011205:Povidone