Journal of Wound Care · 2016 · 14 citations · 17 references
Health ProfessionsPodiatric MedicineSurgeryDiabetic Foot CareDiabetologyNeuropathic Foot DisordersDiabetic Foot DiseaseDiabetic Foot ImagingDiabetic Foot Ulcer CareDiabetic Foot UlcerationDiabetic Neuropathic FootUlcer ManagementChronic Renal InsufficiencyDiabetic Foot DisordersDiabetic Foot Ulcer EvaluationDiabetic Foot Ulcer ImagingMagnetic ResonanceSham TreatmentUlcer Severity GradingWound Healing Monitoring
OBJECTIVE: To test the efficacy and safety of therapeutic magnetic resonance (TMR) in the management of diabetic foot ulcers (DFU), the authors designed a prospective randomised controlled trial in three highly specialised diabetic foot clinics. METHOD: in the foot lasting at least 6 weeks; ABPI>0.6; consent to participate in the study) and exclusion (Charcot's foot; local or systemic infections; chronic renal failure; any wearable electrically-driven life-supporting device) criteria. Patients, who were treated according to international guideline protocols, were randomised into two groups: group A received for four weeks the sham application of TMR, while group B received the active TMR for the same period. People were followed-up to 10 weeks and healing rate (HR), healing time (HT), rate of granulation tissue on wound bed (% GT), reduction of the area of the lesion (∆AL) and a score (0-3) evaluating erythema, oedema, pain and tenderness, respectively, were measured. Adverse events (AE) were registered and monitored throughout the study. RESULTS: No differences were observed in HR, HT and ∆AL between the two groups during follow-up, while % GT and the scores for erythema, oedema and pain at 10 weeks showed significant (p<0.05) improvements in group B compared with group A and versus baseline. When restricted to non-ischaemic patients (ABPI>0.8), ∆AL was significantly (p<0.05) more pronounced in group B than in group A. No difference in AE occurrence was observed between the two groups. CONCLUSION: Our study, despite not being able to demonstrate the effectiveness of TMR on healing rate at 10 weeks, with 4 weeks of active treatment in neuro-ischaemic DFUs, shows positive effects on clinical aspects of the DFU and is associated with a significant increase of GT in the wound bed. DECLARATION OF INTEREST: The study has been fully sponsored by Thereson S.p.A., manufacturer of TMR devices.
17
Benjamin A. Lipsky, Anthony R. Berendt, Paul B. Cornia et al. · Clinical Infectious Diseases · 2012 · 1.7K citations · Full text