The Prevalence of Contact Allergies for Wound Dressings In Patients With Diabetic Foot Ulcers (PAID Study)

NCT04085705 | Unknown DMC

• 1 other identifier: PAID study
• Study Type: observational
• Target: 139
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot; Contact Allergy

Keywords

Wound Dressing

Outcome Measures

Primary Outcomes (1)

• Presence of contact allergy for wound dressings

  The presence of contact allergy for wound dressings

  3 days after application of PATCH test

Secondary Outcomes (1)

• Presence of eczema

  Collected at baseline

Other Outcomes (2)

• Ulcer duration

  Collected at baseline

• Past ulcers

  Collected at baseline

Study Arms (1)

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

Interventions

PATCH test DIAGNOSTIC_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.

Patients with diabetic foot ulcers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rijnstate Hospital: lead

Study Sites (1)

Rijnstate

Arnhem, Gelderland, 6800 TA, Netherlands

RECRUITING

Related Publications (1)

• Visch BM, Veen DV, Smeets L, Toeter R, Bon AV, Romijn D. The Prevalence of Contact Allergies for Wound Dressings in Patients With Diabetic Foot Ulcers (PAID Study), an Observational Prospective Trial. Int J Low Extrem Wounds. 2025 Apr 10:15347346251332028. doi: 10.1177/15347346251332028. Online ahead of print.

  PMID: 40208179 DERIVED

MeSH Terms

Conditions

Diabetic Foot; Dermatitis, Allergic Contact

Interventions

Patch Tests

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Dermatitis, Contact; Dermatitis; Skin Diseases, Eczematous; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Officials

• Birgitte Visch, MD

  Rijnstate

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Birgitte Visch, MD

CONTACT

0031 (0)88-0055081; bvisch@rijnstate.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigaor

Study Record Dates

• First Submitted: September 9, 2019
• First Posted: September 11, 2019
• Study Start: September 17, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: October 18, 2021

Record last verified: 2021-10

Locations

NL (1)