Vitamin D Treatment of Diabetic Patients With Foot Ulcers

• ClinicalTrials.gov Identifier: NCT03813927
• Recruitment Status: Completed
• First Posted: January 23, 2019
• Last Update Posted: January 23, 2019
• Sponsor: Zealand University Hospital
• Information provided by (Responsible Party): Zealand University Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Diabetic Foot Ulcers; Vitamin D Deficiency	Dietary Supplement: Vitamin D; Dietary Supplement: Placebo	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 48 participants
• Allocation: Randomized
• 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

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. Wound healing [ Time Frame: 48 weeks or wound healing. ]
   Wound healing, measured in square cm

Secondary Outcome Measures :

1. Vitamin D blod level status [ Time Frame: 48 weeks or wound healing. ]
   Vitamin D blod level status in intervention Group after supplementation.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Sponsors and Collaborators

Zealand University Hospital

Investigators

• Study Director: Peter Max Halschou-Jensen, MD; Zeeland University Hospital, Denmark

More Information

• Responsible Party: Zealand University Hospital
• ClinicalTrials.gov Identifier: NCT03813927
• Other Study ID Numbers: REG-48-2015
• First Posted: January 23, 2019
• Last Update Posted: January 23, 2019
• Last Verified: January 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Diabetic Foot; Foot Ulcer; Vitamin D Deficiency; Ulcer; Pathologic Processes; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Foot Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Vitamin D; Vitamins; Micronutrients; Nutrients; Growth Substances; Physiological Effects of Drugs; Bone Density Conservation Agents