The Prevalence of Contact Allergies for Wound Dressings in Patients With Diabetic Foot Ulcers (PAID Study), an Observational Prospective Trial.

Abstract

This investigator initiated prospective observational study investigates the prevalence of contact allergies in patients with a Diabetic Foot Ulcer (DFU). Patients with a DFU received a combined PATCH-test (a test used to investigate the origin of an allergic reaction on the skin) at the upper back, with the European baseline series, the European leg ulcer series, and local used material for leg ulcers. A total of 108 patients with DFU were included of which 86 (79.6%) were male, and 9 (8.3%) and 99 (91.7%) patients had Type 1 and Type 2 diabetes, respectively. Twenty-one patients had a sensitization in the standard series, 30 patients in the leg ulcer series, and 11 patients in both series. Two patients had a positive reaction for one of the local used materials. Most frequent sensitizations were found for Perubalsem (N = 6) and Fragrance-Mix II (N = 4) in the standard series. A sensitization for Povidone-Iodine (N = 20) was most frequently seen in the leg ulcer series. In the local used materials a sensitization for silver sulfadiazine (N = 1) and cutimed-gel (n = 1) were seen. In conclusion, this study provides novel information about sensitizations in patients with DFU, but more research is needed to demonstrate the relationship between allergic reactions and delayed wound healing. The study protocol was registered in www.clinicaltrials.gov (NCT04085705, PAID study).