Clinical trial NCT03813927: Vitamin D Treatment of Diabetic Patients With Foot Ulcers
Official title: Systemic Vitamin D Treatment of Diabetic Patients With Foot Ulcers: a Clinical Controlled Investigation of the Effect on Healing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot Ulcers
Vitamin D Deficiency
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2019-01-23
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study, is to determine whether daily supplements of vitamin D improves wound healing in diabetic patients with chronic foot ulcers.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Age \> 18 years
2. Diagnosed diabetes.
3. Foot ulcers more than 6 weeks.
4. Informed consent

Exclusion Criteria:

1. Pregnancy
2. Granulomatous diseases such as tuberculosis, sarcoidosis and silicosis
3. Hypercalcemia
4. Supplementation of vitamin D \> 20 μg a day
5. Renal disease
6. Liver disease
7. Osteomyelitis
8. Skin cancer.
9. Epilepsy.
10. High blod pressure (\> 150/100 mmHg).
11. Indication for surgical revision.

Primary outcomes:
measure: Wound healing
timeFrame: 48 weeks or wound healing.
Secondary outcomes:
measure: Vitamin D blod level status
timeFrame: 48 weeks or wound healing.
Other outcomes:
Locations:
Study officials:
affiliation: Zeeland University Hospital, Denmark
name: Peter Max Halschou-Jensen, MD
role: STUDY_DIRECTOR
References: