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

NCT04085705 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 139

Last updated 2021-10-18

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Rijnstate Hospital

    lead OTHER

Principal Investigators

  • Birgitte Visch, MD · Rijnstate

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-17
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04085705 on ClinicalTrials.gov