Vitamin D Treatment of Diabetic Patients With Foot Ulcers

Study Overview
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Brief Summary
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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
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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.

Official Title
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Systemic Vitamin D Treatment of Diabetic Patients With Foot Ulcers: a Clinical Controlled Investigation of the Effect on Healing

Conditions
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Diabetic Foot Ulcers, Vitamin D Deficiency

Intervention / Treatment
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* Dietary Supplement: Vitamin D
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Diagnosed diabetes. Foot ulcers more than 6 weeks. Informed consent Exclusion Criteria: Pregnancy Granulomatous diseases such as tuberculosis, sarcoidosis and silicosis Hypercalcemia Supplementation of vitamin D > 20 μg a day Renal disease Liver disease Osteomyelitis Skin cancer. Epilepsy. High blod pressure (> 150/100 mmHg). Indication for surgical revision.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D<br>supplementation with tablet 170 μg Vitamin D each day. | Dietary Supplement: Vitamin D<br>* Supplementation with tablet 170 μg Vitamin each day.<br>|
| Placebo Comparator: Placebo<br>Placebo, tablet with 20 μg Vitamin D each day. | Dietary Supplement: Placebo<br>* Placebo with tablet 20 μg Vitamin each day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing | Wound healing, measured in square cm | 48 weeks or wound healing. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin D blod level status | Vitamin D blod level status in intervention Group after supplementation. | 48 weeks or wound healing. |