Vitamin D Treatment of Diabetic Patients With Foot Ulcers
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|ClinicalTrials.gov Identifier: NCT03813927|
Recruitment Status : Completed
First Posted : January 23, 2019
Last Update Posted : January 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Foot Ulcers Vitamin D Deficiency||Dietary Supplement: Vitamin D Dietary Supplement: Placebo||Not Applicable|
"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".
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.
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||Systemic Vitamin D Treatment of Diabetic Patients With Foot Ulcers: a Clinical Controlled Investigation of the Effect on Healing|
|Actual Study Start Date :||April 1, 2016|
|Actual Primary Completion Date :||December 31, 2017|
|Actual Study Completion Date :||July 3, 2018|
Experimental: Vitamin D
supplementation with tablet 170 μg Vitamin D each day.
Dietary Supplement: Vitamin D
Supplementation with tablet 170 μg Vitamin each day.
Placebo Comparator: Placebo
Placebo, tablet with 20 μg Vitamin D each day.
Dietary Supplement: Placebo
Placebo with tablet 20 μg Vitamin each day.
- Wound healing [ Time Frame: 48 weeks or wound healing. ]Wound healing, measured in square cm
- Vitamin D blod level status [ Time Frame: 48 weeks or wound healing. ]Vitamin D blod level status in intervention Group after supplementation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03813927
|Study Director:||Peter Max Halschou-Jensen, MD||Zeeland University Hospital, Denmark|