Tolerability and safety of conventional therapy combination with DeMarco formula for infected ischemic diabetic foot
| Autor: | José Hernández Carretero, Héctor Álvarez Duarte, Miriam Mahía Vilas, Martha M. Fors López, Milagros García Mesa |
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| Rok vydání: | 2010 |
| Předmět: |
Male
medicine.medical_specialty Pilot Projects Dermatology Gastroenterology Amputation Surgical Pathology and Forensic Medicine Lesion chemistry.chemical_compound Internal medicine medicine Humans Dosing Anesthetics Local Adverse effect Creatinine biology business.industry Povidone Bacterial Infections Middle Aged medicine.disease Combined Modality Therapy Diabetic foot Rash Diabetic Foot Surgery Drug Combinations Treatment Outcome Tolerability chemistry Alanine transaminase biology.protein Female medicine.symptom business Procaine Follow-Up Studies |
| Zdroj: | Journal of Tissue Viability. 19:116-122 |
| ISSN: | 0965-206X |
| DOI: | 10.1016/j.jtv.2010.03.002 |
| Popis: | 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 (0.15ml/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 51.29cm 2 at the beginning to 1.89cm 2 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. |
| Databáze: | OpenAIRE |
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