Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Vitamin D Treatment of Diabetic Patients With Foot Ulcers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03813927
Recruitment Status : Completed
First Posted : January 23, 2019
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
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.

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.


Layout table for study information
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

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

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.




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.

Information from the National Library of Medicine

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


Sponsors and Collaborators
Zealand University Hospital
Investigators
Layout table for investigator information
Study Director: Peter Max Halschou-Jensen, MD Zeeland University Hospital, Denmark

Layout table for additonal information
Responsible Party: Zealand University Hospital
ClinicalTrials.gov Identifier: NCT03813927     History of Changes
Other Study ID Numbers: REG-48-2015
First Posted: January 23, 2019    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for 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
Ergocalciferols
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents