Original articleEvaluation of the moisturizer Pédimed® in the foot care of diabetic patientsÉvaluation de l’émollient Pédimed® dans la prise en charge du pied du diabétique
Introduction
Diabetic foot is characterized by abnormalities and neuropathy-related issues that increase the risk of chronic ulcers. While chronic sensorimotor diabetic peripheral neuropathy can cause a progressive loss of protective sensations and foot deformities, autonomic neuropathy is considered to play a major role in promoting anhidrosis, hyperkeratosis and callus formation in weight-bearing areas due to sudomotor dysfunction [1]. All these abnormalities predispose patients to foot ulceration, as emphasized by the International Working Group on the Diabetic Foot [2]. Moreover, xerosis has a weakening effect on the stratum corneum (superficial skin layer) that may lead to cracks and fissures [3] and, subsequently, to foot infections [4]. After assessing the risk factors for ulceration in diabetic patients, Litzelman et al. [5] noted that 82.1% of diabetic patients also suffered from xerosis, combined or not with fissures or cracks. As a result, preventing ulceration is paramount, as more than 2% of these patients will develop new foot ulcers each year after an initial episode [6].
Simple measures, including the treatment of dry skin and fissures, are effective in preventing foot ulcers [7], [8], [9]. The management of dry or fissured skin is based on the application of a topical moisturizer as soon as xerosis is detected [10]. The aim is to improve cell hydration so as to restore skin softness and elasticity [11].
Moisturizing creams are generally based on glycerine, paraffin, urea and lactic acid. By forming a lipid layer on the skin surface (occlusive action), glycerine and paraffin help to improve skin barrier function and prevent dehydration, thus reducing transepidermal water loss. On the other hand, glycerine, urea and lactic acid are part of the so-called ‘natural moisturizing factor’, a group of water-soluble substances responsible for maintaining water within the keratinized epidermal layers of the skin [11]. The properties of urea are concentration-dependent, with moisturizing effects at 5%, desquamation action at 20% and keratolytic action at 40% [12]. Lactic acid is a hygroscopic water-soluble compound characterized by its high water-capturing ability and excellent substantivity on cutaneous proteins, enabling long-lasting efficacy. The properties of these constituents, together with their complementary action (namely, mechanical barrier function and skin hydration) form the basis of their benefits in the treatment of xerosis [11], [13]. Several studies have focused on the efficacy of moisturizers in a variety of dry skin conditions [14], [15], [16], [17], but only one assessed their impact on the feet of diabetic patients [18]. In that study, Pham et al. demonstrated the efficacy of a cream containing 10% urea and 4% lactic acid in the treatment of xerosis of the feet.
The aim of the present study was to assess both the efficacy and safety of Pédimed®, a moisturizer specifically designed for the treatment of xerosis of the feet in diabetic patients.
Section snippets
Methods
The present randomized, double-blind, placebo-controlled study was conducted at the European Skin Research Centre at Hôtel-Dieu in Toulouse, France. The objective was to compare the moisturizing properties of Pédimed® with those of a placebo. Each patient served as his/her own control. Pédimed® and the placebo were randomly allocated to either the right or left foot of each patient (resulting in one active and one control foot). The study was performed in accordance with the principles of the
Results
Sixty-three patients were screened for this study and 55 (87.3%) were included. Four patients failed to meet the criteria for xerosis–two had psoriasis and two women were not using the appropriate contraceptive methods. Of the 55 patients included, 54 completed the study and were included in the analyses. One patient was excluded before the study started because he was within the exclusion period of another trial, a criterion stipulated by the French National Volunteer Database.
The demographic
Discussion
The aim of the present study was to demonstrate both the efficacy and safety of Pédimed® in the treatment of foot xerosis in diabetic patients. Each patient served as his/her own control (Pédimed® or the placebo being randomly assigned to the right/left foot). The study population was similar to the national sample that was representative of the French diabetic patients included in the ENTRED (Echantillon National Témoin Représentatif des Personnes Diabétiques) study [21] in terms of
Conflict of interest statement
E.G., A.R. and A.D. are employees of Pierre Fabre Laboratories. J.M. has been a member of the Advisory Board, has served as a principal investigator, and has received fees for medical presentations from Pierre Fabre Laboratories. F.C.P. has served as an investigator.
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The role of foot self-care behavior on developing foot ulcers in diabetic patients with peripheral neuropathy: A prospective study
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