Status:
UNKNOWN
The Prevalence of Contact Allergies for Wound Dressings In Patients With Diabetic Foot Ulcers (PAID Study)
Lead Sponsor:
Rijnstate Hospital
Conditions:
Diabetic Foot
Contact Allergy
Eligibility:
All Genders
18+ years
Brief Summary
Rationale: Foot ulcers among diabetics are common. The presence of a contact allergy limits the healing process. Contact allergies for wound dressings are common among patients with ulcers caused by v...
Detailed Description
Foot ulcers among diabetics are common. In 2015, around 20,000 patients in the Netherlands had a diabetic foot ulcer.1 A study using data from Dutch general practices found a prevalence rate of 0.50% ...
Eligibility Criteria
Inclusion
- Age of 18 years or older;
- Diagnosed with type 1 or 2 diabetes mellitus;
- Diagnosed with diabetic foot ulcer;
- Provided written informed consent.
Exclusion
- Patient unwilling or unlikely to comply with the study procedures
- Patient receiving systemic corticosteroid therapy during PATCH testing (patient should stop with corticosteroid therapy three days before PATCH testing, and may start when testing and reading is done)
- Patient receiving antihistaminic therapy during PATCH testing (patient should stop with antihistaminic therapy three days before PATCH testing, and may start when testing and reading is done)
Key Trial Info
Start Date :
September 17 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
139 Patients enrolled
Trial Details
Trial ID
NCT04085705
Start Date
September 17 2019
End Date
December 1 2022
Last Update
October 18 2021
Active Locations (1)
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1
Rijnstate
Arnhem, Gelderland, Netherlands, 6800 TA