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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
Sponsor:
Information provided by (Responsible Party):
Birgitte Maessen, Rijnstate Hospital

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 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

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Study Type : Observational
Estimated Enrollment : 139 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. Presence of contact allergy for wound dressings [ Time Frame: 3 days after application of PATCH test ]
    The presence of contact allergy for wound dressings


Secondary Outcome Measures :
  1. Presence of eczema [ Time Frame: Collected at baseline ]
    Presence of eczema/dermatitis


Other Outcome Measures:
  1. Ulcer duration [ Time Frame: Collected at baseline ]
    Duration of ulcers

  2. Past ulcers [ Time Frame: Collected at baseline ]
    The number of ulcers in the past



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The study population are high risk diabetic patients with a foot ulcer visiting the multidisciplinary consultation hour for diabetics at the clinic.

Diabetic patients are patients diagnosed with type 1 or type 2 diabetes.

Criteria

Inclusion Criteria:

  • Age of 18 years or older;
  • Diagnosed with type 1 or 2 diabetes mellitus;
  • Diagnosed with diabetic foot ulcer;
  • Provided written informed consent.

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

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


Contacts
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Contact: Birgitte Visch, MD 0031 (0)88-0055081 bvisch@rijnstate.nl

Locations
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Netherlands
Rijnstate Not yet recruiting
Arnhem, Gelderland, Netherlands, 6800 TA
Contact: Birgitte Visch, MD    0031 (0)88-0055081,    bvisch@rijnstate.nl   
Sponsors and Collaborators
Rijnstate Hospital
Investigators
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Principal Investigator: Birgitte Visch, MD Rijnstate

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Responsible Party: Birgitte Maessen, Principal Investigaor, Rijnstate Hospital
ClinicalTrials.gov Identifier: NCT04085705     History of Changes
Other Study ID Numbers: PAID study
First Posted: September 11, 2019    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Birgitte Maessen, Rijnstate Hospital:
Wound Dressing
Additional relevant MeSH terms:
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Dermatitis, Allergic Contact
Dermatitis, Contact
Diabetic Foot
Foot Ulcer
Hypersensitivity
Immune System Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases
Dermatitis
Skin Diseases, Eczematous
Hypersensitivity, Delayed