Vitamin D Deficiency Clinical Trial
Official title:
Systemic Vitamin D Treatment of Diabetic Patients With Foot Ulcers: a Clinical Controlled Investigation of the Effect on Healing
The purpose of this study, is to determine whether daily supplements of vitamin D improves wound healing in diabetic patients with chronic foot ulcers.
Project title
"Treatment with oral vitamin D in diabetic patients with chronic foot ulcers on the lower
limb; a clinical controlled study of the effect on wound healing".
Abstract
Aims and objectives
The purpose of this study is to determine whether daily supplements of vitamin D improves
wound healing in diabetic patients with chronic foot ulcers.
Background
Lifetime risk of developing chronic lower extremity ulcers summarized in type I and type II
diabetics is about 25% and the prevalence is approximately 7%. There is often a long term
resource consuming disorder where 47% of the diabetic leg and foot ulcers effectively can be
treated within 12 months.
In Denmark in 2011 there were more than 300,000 diagnosed type I and type II diabetics, and
estimated about 200,000 undiagnosed type II diabetics. Therefore, approximately 35,000
diabetics each year are treated for chronic leg or foot ulcers in the Danish health sector.
The treatment of these chronic wounds are associated with significant costs, as well as
emotional, physical and financial.
Vitamin D deficiency is a widespread problem, and it is estimated that worldwide there is 1
billion people suffering from vitamin D deficiency. A Danish study from 2012 showed vitamin D
deficiency in 52% of adults aged 30 60 years. Vitamin D deficiency is more common in
diabetics with chronic foot or leg ulcers, when compared with non diabetics and diabetics
without ulcers.
Methods and materials
48 diabetic patients with chronic foot ulcers will be included in the study. The patients
will be recruited from the outpatient clinic, department of orthopaedic surgery at Zealand
University Hospital, Denmark. The patients will randomly be divided into two groups,
respectively treated with vitamin D or placebo.
Expected outcome and perspectives
The investigators expect that this study will show that supplementation with oral vitamin D,
will result in a significant effect on wound treatment and healing for a large group of
diabetic patients with chronic foot ulcers. This will contribute to a changed procedure in
this specific group of patients, leading to measurement of vitamin D status and
supplementation with vitamin D if needed.
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