NCT03813927

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 23, 2019

Completed
Last Updated

January 23, 2019

Status Verified

January 1, 2019

Enrollment Period

1.8 years

First QC Date

January 9, 2019

Last Update Submit

January 21, 2019

Conditions

Diabetic Foot UlcersVitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

  • Wound healing

    Wound healing, measured in square cm

    48 weeks or wound healing.

Secondary Outcomes (1)

  • Vitamin D blod level status

    48 weeks or wound healing.

Study Arms (2)

Vitamin D

EXPERIMENTAL

supplementation with tablet 170 μg Vitamin D each day.

Dietary Supplement: Vitamin D

Placebo

PLACEBO COMPARATOR

Placebo, tablet with 20 μg Vitamin D each day.

Dietary Supplement: Placebo

Interventions

Vitamin DDIETARY_SUPPLEMENT

Supplementation with tablet 170 μg Vitamin each day.

Vitamin D
PlaceboDIETARY_SUPPLEMENT

Placebo with tablet 20 μg Vitamin each day.

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years
  • Diagnosed diabetes.
  • Foot ulcers more than 6 weeks.
  • Informed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetic FootVitamin D Deficiency

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic NeuropathiesAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Peter Max Halschou-Jensen, MD

    Zeeland University Hospital, Denmark

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2019

First Posted

January 23, 2019

Study Start

April 1, 2016

Primary Completion

December 31, 2017

Study Completion

July 3, 2018

Last Updated

January 23, 2019

Record last verified: 2019-01