A PROPOSED STUDY OF THE EFFECTS OF A MOISTURIZING PRODUCT ON DRY DIABETIC FEET
Date of Award
Master of Science in Orthotics and Prosthetics
Introduction: Diabetic foot syndrome causes changes to the skin barrier including neuropathy and dry skin. Left untreated, this can lead to amputation. It has been suggested that diabetic skin may benefit from regular moisturizer use to treat dry skin.
A proposed cohort research study of diabetic patients with dry skin designed to evaluate the efficacy of daily or weekly use of a moisturizing matrix-suspended emollient/occlusive foot soak.
Methods: A minimum of 150 diabetic patients with mild-to-moderate dry skin conditions would be recruited from podiatrists or O&P clinics. With informed patient consent, they would be randomly selected to be in a control group (no moisturizer use), a 1x daily use, or a 1x weekly use group to use the moisturizing matrix-suspended emollient/occlusive foot soak. Both physician (blinded to group assignment) and subjects would assess skin condition at baseline (day 0) versus end (day 28 +/-5 days) using a dry skin classification scale and the Global Aesthetic Improvement Scale (GAIS). Subjects would also rate quality of life (QOL) before the trial and after, noting improvement, product satisfaction, safety and tolerability.
Hypothesis: Both Physicians and patients will report improvement on the dry skin classification scale and quality of life (QOL) measures. Physicians will report improvement of dry skin from the baseline (day 0) to end (day 28 +/- 5 days) on the GAIS. Patients using moisturizing foot soak daily will show the most improvement of dry skin and QOL, patients using it weekly will show some improvement of dry skin and QOL. Patients in the control group will show no improvement on dry skin classification or QOL.
Significance: This study will show whether this product is effective at improving dry skin conditions and quality of life for diabetic patients.