Vitamin D Treatment of Diabetic Patients With Foot Ulcers

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03813927
• Other study ID #: REG-48-2015
• Status: Completed
• Phase: N/A
• Start date: April 1, 2016
• Est. completion date: July 3, 2018

Study information

• Verified date: January 2019
• Source: Zealand University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 3, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcers
• Foot Ulcer
• Ulcer
• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Vitamin D
Supplementation with tablet 170 µg Vitamin each day.
• Placebo
Placebo with tablet 20 µg Vitamin each day.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zealand University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound healing	Wound healing, measured in square cm	48 weeks or wound healing.
Secondary	Vitamin D blod level status	Vitamin D blod level status in intervention Group after supplementation.	48 weeks or wound healing.