De Marco Formula effectiveness as an adjunctive therapy to prevent infected ischemic diabetic foot amputation and reduce plasma fibrinogen

BackgroundDe Marco Formula (DMF) is a new procaine chemical combination of Procaine HCl and polyvinylpyrrolidone. A prospective randomized controlled clinical trial demonstrated that infected ischemic diabetic foot treatment with DMF for 52 days as an adjuvant with conventional therapy reduced major amputations.ObjectiveTo evaluate the possible association of clinical effectiveness and plasma fibrinogen reduction with DMF therapy.MethodsAdult patients, 24 male/23 female, suffering from infected ischemic diabetic foot ulcers were randomly assigned to receive conventional therapy alone (group A, N = 24) or combined with DMF (receiving 0, 15 ml/kg day i.m.) for ten days and then twice a week until lesion healing or completion of 52 days (group B, N = 23). Fibrinogen concentrations were determined before and after a ten-day treatment period. Treatment clinical responses were considered favorable if major amputations were not needed. Pre and post-treatment fibrinogen values were compared within each group and between groups. Differences were considered statistically significant for p < 0, 05.ResultsFifty percent of group A patients (12/24) and 21.7% of the Group B (5/23) showed unfavorable responses (a 56.6% reduction for group B). There were not statistical differences between pre and post-treatment fibrinogen within Group A (406.7 ± 49.08 vs. 354.6 ± 62.5, p = 0,11). However, post-treatment values were significantly lower within Group B (298.9 ± 15.24 vs. 487.1 ± 49.08, p = 0, 0016). Patients who showed favorable responses had statistically lower fibrinogen concentrations than those with unfavorable responses (280 ± 5.1 vs. 310 ± 7,1, p = 0.002) within group B.ConclusionDMF combined with conventional therapy for infected ischemic diabetic foot was associated with plasma fibrinogen decrease.