sefulness of vitamin D supplements for treating diabetic foot infections

Not Applicable

Conditions: Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications

Registration Number: CTRI/2019/06/019714

Lead Sponsor: Manipal McGill Center for Infectious Diseases

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Confirmed diagnosis of DM type 1 or 2.

2.Presence of 1 or more DFU, less than 15 cm in

its biggest diameter, with a Texas University

score <= 2. (For DFU patients)

3.Low Serum vitamin D level (Cohort study)

4.Prescribed with oral vitamin D supplements

about the equivalent to 3,300 IU/day for 3

months (Study Cohort)

5.Clinical evidence of foot infection diagnosed

by culture positivity and/or leucocytes in the

presence of fever. [For diabetic foot infection

(DFI) patients]

6.Pharmacological treatment for both glycemic

control and foot infection.

7.Willingness to participate in the study and to

give the informed consent form.

Exclusion Criteria

1.Unconfirmed DM diagnosis.

2.Any pathology that, based on the judgment of

the researcher, could alter the course of DFU

(neoplasias, immunological disorders, etc).

3.Renal insufficiency requiring dialysis

treatment.

4.DFU with a Texas score >2.

5.Critical ischemia of IL diagnosed by Doppler

ultrasound and defined by ankle/arm index

< 0.5.

6.Clinical findings suggesting complicated venous

insufficiency of IL.

7.Distal necrosis of the limb with the ulcer.

8.Pregnant or breastfeeding women.

9.Mentally or neurologically disabled patients

that are considered not fit to approve their

participation in the study.

10.Patients having clinical evidence of vascular

insufficiency or taking immunosuppressants,

multivitamins, Ca supplements and drugs that

interfere with vitamin D metabolism were

excluded from the study. (Cohort study)

11.Unwilling to give informed consent.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is clinical (wound healing, severity of infection), biochemical (Serum Vitamin D, WBC, culture sensitivity, ESR, CRP, blood glucose level, HbA1C) and HRQoL changes from baseline to 4 months post supplementation with vitamin D supplements.Timepoint: At baseline and at 4 months post supplementation of vitamin D

Secondary Outcome Measures

Name	Time	Method
Improvement in quality of life measures at 4 months after the vitamin D supplementsTimepoint: Baseline and after 4 months of supplementation with vitamin D supplements