The Prevalence of Contact Allergies for Wound Dressings In Patients With Diabetic Foot Ulcers (PAID Study) (PAID)
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|ClinicalTrials.gov Identifier: NCT04085705|
Recruitment Status : Not yet recruiting
First Posted : September 11, 2019
Last Update Posted : September 11, 2019
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 venous insufficiency but less is known about contact allergies in diabetic patients with ulcers.
Objective: To determine the prevalence of contact allergies for wound dressings in patients with diabetic foot ulcers.
Study design: A prospective multicenter study.
Study population: Patients (n=139) with diabetic foot ulcers caused by type 1 or 2 diabetes mellitus treated at Rijnstate Hospital Arnhem, the Netherlands.
Main study parameters/endpoints: The primary study parameter is the presence of contact allergies for wound dressings.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: An allergy test is standard procedure at Rijnstate Hospital, there is no direct technique-related burden or risk for the patient. In addition, wound dressings can be adjusted in patients where a contact allergy is determined which will benefit the prognosis of these patients. The data of this study will give insight in the prevalence of contact allergies for wound dressings in patients with diabetic foot ulcers.
|Condition or disease||Intervention/treatment|
|Diabetic Foot Contact Allergy||Diagnostic Test: PATCH test|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||139 participants|
|Official Title:||The Prevalence of Contact Allergies for Wound Dressings In Patients With Diabetic Foot Ulcers|
|Estimated Study Start Date :||September 2019|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
Patients with diabetic foot ulcers
All patients with diabetic foot ulcers will undergo a PATCH test to determine the prevalence of contact allergies against wound dressings.
Diagnostic Test: PATCH test
The PATCH test is a method used to determine whether a specific substance causes allergic inflammation of a patient's skin, in this case contact allergy for wound dressings. Two days after PATCH test is applied, the patches are removed. The next day, the presence of a contact allergy is determined.
- Presence of contact allergy for wound dressings [ Time Frame: 3 days after application of PATCH test ]The presence of contact allergy for wound dressings
- Presence of eczema [ Time Frame: Collected at baseline ]Presence of eczema/dermatitis
- Ulcer duration [ Time Frame: Collected at baseline ]Duration of ulcers
- Past ulcers [ Time Frame: Collected at baseline ]The number of ulcers in the past
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04085705
|Contact: Birgitte Visch, MD||0031 (0)firstname.lastname@example.org|
|Rijnstate||Not yet recruiting|
|Arnhem, Gelderland, Netherlands, 6800 TA|
|Contact: Birgitte Visch, MD 0031 (0)88-0055081, email@example.com|
|Principal Investigator:||Birgitte Visch, MD||Rijnstate|