The Prevalence of contact Allergies for wound dressings In patients with Diabetic foot ulcers.

The Prevalence of contact Allergies for wound dressings In patients with Diabetic foot ulcers. - PAID study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON48136

Enrollment

139

Registered

2019-07-25

Start date

2019-09-17

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contact allergy

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion 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

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)

Design outcomes

Primary

Measure	Time frame
The presence of contact allergy for wound dressings	—

Secondary

Measure	Time frame
The following factors will be gathered at baseline: - Age - Gender - Diabetes type - Duration of diabetes - Medication use - Ulcer characteristics like type, size, duration, progress (TEXAS classification) - Number of past foot ulcers - Duration of past foot ulcers - Known allergies or atopy constitution - Presence of allergic contact dermatitis around the wound - Doses corticosteroid or antihistaminic therapy (not during PATCH testing) - History of eczema Parameters to define if there are other mechanisms besides diabetics underlying the ulcer: - Ankle brachial index , toe pressure measurement or Transcutaneous oxygen pressure (TcPo2) - Venous insufficiency which is measured by a venous duplex, if applicable Parameters related with contact allergy or parameters that can influence the development of a contact allergy: - Known allergy. If yes, which allergy/allergies? - Duration of current ulcus cruris - Number of past ulcers - Treatment with wound dressing(s) current episode: o Duration of ulcer - Treatment with wound dressing(s) prior episode(s) - Prevalence of allergic contact dermatitis	—

Measure

Time frame

The following factors will be gathered at baseline: - Age - Gender - Diabetes type - Duration of diabetes - Medication use - Ulcer characteristics like type, size, duration, progress (TEXAS classification) - Number of past foot ulcers - Duration of past foot ulcers - Known allergies or atopy constitution - Presence of allergic contact dermatitis around the wound - Doses corticosteroid or antihistaminic therapy (not during PATCH testing) - History of eczema Parameters to define if there are other mechanisms besides diabetics underlying the ulcer: - Ankle brachial index , toe pressure measurement or Transcutaneous oxygen pressure (TcPo2) - Venous insufficiency which is measured by a venous duplex, if applicable Parameters related with contact allergy or parameters that can influence the development of a contact allergy: - Known allergy. If yes, which allergy/allergies? - Duration of current ulcus cruris - Number of past ulcers - Treatment with wound dressing(s) current episode: o Duration of ulcer - Treatment with wound dressing(s) prior episode(s) - Prevalence of allergic contact dermatitis

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Countries

Netherlands

Outcome results