Vitamin D Treatment of Diabetic Patients With Foot Ulcers

Not Applicable

Completed

• Conditions: Diabetic Foot Ulcers; Vitamin D Deficiency
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Vitamin D

• Registration Number: NCT03813927
• Lead Sponsor: Zealand University Hospital

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.

Study Timeline

• Study Start: 2016-04-01
• Primary Completion: 2017-12-31
• Study Completion: 2018-07-03
• Status Verified: 2019-01
• Study First Submitted: 2019-01-09
• Study First Submitted QC: 2019-01-21
• Last Update Submitted: 2019-01-21
• Study First Posted: 2019-01-23
• Last Update Posted: 2019-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo, tablet with 20 μg Vitamin D each day.
Vitamin D	Vitamin D	supplementation with tablet 170 μg Vitamin D each day.

Primary Outcome Measures

Name	Time	Method
Wound healing	48 weeks or wound healing.	Wound healing, measured in square cm

Secondary Outcome Measures

Name	Time	Method
Vitamin D blod level status	48 weeks or wound healing.	Vitamin D blod level status in intervention Group after supplementation.