BACKGROUND: De 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. OBJECTIVE: To evaluate the possible association of clinical effectiveness and plasma fibrinogen reduction with DMF therapy. METHODS:Adult 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. RESULTS: Fifty 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. CONCLUSION:DMF combined with conventional therapy for infected ischemic diabetic foot was associated with plasma fibrinogen decrease.
RCT Entities:
BACKGROUND: De 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. OBJECTIVE: To evaluate the possible association of clinical effectiveness and plasma fibrinogen reduction with DMF therapy. METHODS: Adult 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. RESULTS: Fifty 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. CONCLUSION:DMF combined with conventional therapy for infected ischemic diabetic foot was associated with plasma fibrinogen decrease.