ABSTRACT
AIM: Xerosis is one of the most common abnormalities observed in the diabetic foot, promoting ulceration through the development of fissures and hyperkeratosis. Its treatment is therefore paramount and must be implemented early on. The objective of this study was to assess the moisturizing properties of Pédimed(®) cream in the treatment of foot xerosis in diabetic patients. METHODS: In this randomized double-blind study, Pédimed(®) and its placebo were randomly allocated to the right/left foot of each patient (one active/one control side). Products were applied twice daily for 4 weeks. Xerosis was assessed using the clinical Xerosis Assessment Scale (XAS), corneometry (skin hydration measurement) and D-Squame(®) (scale sample analysis) after 14 (D14) and 28 (D28) days of treatment. RESULTS: Twenty-four men and 30 women, aged 57.0±12.7 years, with type 1 or type 2 diabetes and moderate-to-severe foot xerosis were included. A dramatic decrease in XAS score that was more marked with Pédimed(®) than with placebo was observed from D14 (38.1% vs 20.9%, P<0.0001), reaching 61.9% vs 34.9% at D28 (P<0.0001). The number of feet with fissures was greatly reduced with Pédimed(®) compared with placebo at both D14 (11.1% vs 22.2%, P=0.031) and D28 (5.6% vs 18.5%, P=0.039). Skin hydration increased by 48.9% with Pédimed(®) vs 31.7% with placebo at D14 (P=0.0002), reaching 57.3% vs 36.5% at D28 (P<0.0001). All D-Squame(®) parameters showed greater improvement with Pédimed(®). Product tolerability was excellent. CONCLUSION: Validated clinical and paraclinical tools demonstrated the efficacy of Pédimed(®) in improving xerosis and reducing fissures of the feet in diabetic patients.
Subject(s)
Dermatologic Agents/administration & dosage , Diabetes Mellitus, Type 2/complications , Diabetic Foot/drug therapy , Emollients/administration & dosage , Adolescent , Adult , Aged , Dermatologic Agents/adverse effects , Diabetic Foot/pathology , Double-Blind Method , Emollients/adverse effects , Female , Humans , Male , Middle Aged , Placebos , Severity of Illness Index , Skin/drug effects , Skin/pathologyABSTRACT
Diabetic foot ulcers are a frequent and severe complication of diabetes mellitus. A multidisciplinary approach (in-patient and out-patient care) improves prognosis and reduces the amputation rate. Risk factors are well defined and easily identified. High-risk patients (sensory loss, vascular disease, previous ulcer, foot deformities) have to be detected. In France, comprehensive foot-care programs, including education and regular foot examination, must be developed. The reduction of the economical and human burden needs the urgent formation of more multidisciplinary teams (to take care of patients properly and very early), foot care networks, and prevention programs.
