The primary objective of this study is to determine the prevalence of contact allergies in patients with diabetic foot ulcers.
ID
Source
Brief title
Condition
- Administration site reactions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The presence of contact allergy for wound dressings
Secondary outcome
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
Background summary
Foot ulcers among diabetics are common. In 2015, around 20,000 patients in the
Netherlands had a diabetic foot ulcer.1 A study using data from Dutch general
practices found a prevalence rate of 0.50% and a 4-year prevalence rate of
2.85%.2 For Europe, Zhang et al. estimated a pooled prevalence of 5.1% (95%CI:
4.1*6.0%).3 Prevalence rates increase with age.
The underlying mechanism of diabetic foot ulcers is most often solely
neuropathy (60 to 70%), 15 to 20% have peripheral artery disease (PAD) only,
and 15 to 20% have a mixture of both.4 Diabetic foot is more prevalent in males
and more prevalent in type 2 diabetes than in type 1 diabetes3. Ulcers in
patients without diabetes are mostly caused by venous insufficiency.5
Ulcers have a slow healing tendency. Around 15 percent of diabetic patients
with an ulcer eventually have to amputate (a part of) the leg.1 Good wound care
is therefore important. However, wound care can be delayed in the presence of a
contact allergy. Contact allergy (synonym for contact sensitivity) is defined
as an altered immune status of an individual induced by a particular
sensitizing substance, a contact allergen. An individual in whom contact
allergy has been induced will develop a secondary immune response if there is
skin exposure to the same (or cross*reacting) allergen. This process is called
elicitation, and will manifest as allergic contact dermatitis (type IV
hypersensitivity).6 Allergic contact dermatitis, also termed allergic contact
eczema, is defined as an inflammatory skin reaction caused by direct contact
with noxious agents in the environment as a result of contact allergy.
Among patients with venous leg ulcers contact allergies is seen in around 50
percent of which 10-20% for wound dressings.7-10 The prevalence of contact
allergies is getting higher and also increasing with the duration of the ulcer.
8,10 Wound dressings can cause allergic contact eczema (allergic contact
dermatitis).
At present, the prevalence of contact allergies for wound dressings in diabetic
patients with foot ulcers is unknown. With this study we want to gain insight
in the prevalence of contact allergies in patients with diabetic foot ulcers
and investigate if the prevalence of contact allergies among diabetic patients
is as high as the prevalence in patients with venous leg ulcers.
Study objective
The primary objective of this study is to determine the prevalence of contact
allergies in patients with diabetic foot ulcers.
Study design
This is a prospective, single center study. (intention to include more centers
at the end of 2019)
Study burden and risks
Not applicable
Wagnerlaan 55
Arnhem 6815AD
NL
Wagnerlaan 55
Arnhem 6815AD
NL
Listed location countries
Age
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)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL69346.091.19 |