Healing of Neuropathic Diabetic Foot Ulcers of PEDIS Grade 1-2 at Home Care with Topical Antiseptics: An Observational Follow-Up Investigation

Abstract

Objective: This observational and clinical prospective follow-up study examined the healing of ordinary diabetic foot ulcers at home-care setting with two commercially available topical antiseptics, one in formulation as a solution and the other one as a salve. Method:The study population consisted of 35 consecutive adult outpatients with diabetic foot ulcers that were classified as grades 1-2 by using the PEDIS (Perfusion, Extent, Depth, Infection and Sensation) classification system. The patients were treated by two commercial antiseptics (Abilar ® 10% Resin Salve or Octenidine ® solution) and followed-up by a specialized clinic with four follow-up visits during a treatment period of 145 days on average. All patients performed the wound care at home after instructions from the clinic.Results: At study entry, the mean ulcer area was 221 mm 2 (median 140 mm 2 , interquartile range: 73-320 mm 2 ) in the salve group and 277 mm 2 (median 132 mm 2 , interquartile range: 50-365 mm 2 ) in the solution group. In intentto-treat (ITT) analysis of the whole study population of 35 patients, the ulcers healed totally in 14 (37%; 95% CI 24-56%), and in 9 of 19 patients (47%; 95% CI: 25%-77%) and in 5 of 16 patients (31%; 95% CI: 9%-54%) in the resin salve and Octenidine solution groups, respectively (P>0.05). The infected ulcer with small median size showed an insignificant trend to heal better than the other ulcers. The number of positive bacterial cultures from ulcers (bacteria of Staphylococcus and Streptococcus species in great majority of cases), taken on clinical grounds if infection was suspected, was lower in follow-up visits than at study entry. No side effects were observed. Conclusion:Treatment of diabetic foot ulcers of PEDIS grade 1-2 at home-care with topical antiseptics is an option that results in complete healing of ulcer in more than one third of cases in a 145-day treatment period.