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

Milagros García Mesa1, Héctor Álvarez Duarte, José Hernández Carretero

  • 1National Institute for Angiology and Vascular Surgery, Research Department, 1551 Calzada del Cerro, Postal code 12000, Havana City, Cuba. milagros.mesa@infomed.sld.cu

Journal of Tissue Viability
|January 8, 2011
PubMed
Abstract

Insights

De Marco Formula (DMF), a procaine combination, reduced major amputations in diabetic foot ulcers when used with conventional therapy. DMF also significantly decreased plasma fibrinogen levels in patients with improved clinical outcomes.

Area of Science:

  • Vascular Surgery
  • Diabetology
  • Pharmacology

Background:

  • Infected ischemic diabetic foot ulcers pose a significant risk of major amputations.
  • De Marco Formula (DMF) is a novel combination of Procaine HCl and polyvinylpyrrolidone.
  • Previous studies indicated DMF's potential in reducing amputations when used as an adjuvant therapy.

Purpose of the Study:

  • To investigate the association between De Marco Formula (DMF) therapy and clinical effectiveness in treating infected ischemic diabetic foot ulcers.
  • To evaluate the impact of DMF therapy on plasma fibrinogen levels.
  • To correlate changes in fibrinogen with treatment outcomes.

Main Methods:

  • A prospective randomized controlled trial involving 47 patients with infected ischemic diabetic foot ulcers.
  • Patients were assigned to conventional therapy alone (Group A, N=24) or combined with DMF (Group B, N=23).
  • Plasma fibrinogen levels were measured before and after a 10-day treatment period, with DMF administered for 52 days or until healing.

Main Results:

  • Group B (DMF + conventional therapy) experienced a 56.6% reduction in major amputations compared to Group A (conventional therapy alone).
  • Significant reduction in plasma fibrinogen was observed in Group B (p=0.0016) but not in Group A (p=0.11).
  • Favorable treatment responses in Group B were associated with statistically lower post-treatment fibrinogen levels (p=0.002).

Conclusions:

  • De Marco Formula (DMF) combined with conventional therapy is associated with a significant decrease in plasma fibrinogen levels.
  • The reduction in fibrinogen may play a role in the observed clinical effectiveness of DMF in treating infected ischemic diabetic foot ulcers.
  • DMF demonstrates promise as an adjunctive treatment for improving outcomes in patients with this condition.

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