Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
Conditions
Interventions
Control Intervention1: NIL: NIL
Sponsors
Manipal McGill Center for Infectious Diseases
Eligibility
Inclusion criteria
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 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
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactSonal Sekhar M
Manipal College of Pharmaceutical Sciences
Outcome results
None listed