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

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.

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. CONCLUSION: 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.

Clinical evaluation of De Marco formula as an adjunctive therapy for infected ischemic diabetic foot: a prospective randomized controlled trial.

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. CONCLUSION: 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.