sefulness of Vitamin D Supplements and its Receptor Genetic variations in sugar patients with Infection of Foot from Southern part of India
- Conditions
- Health Condition 1: E106- Type 1 diabetes mellitus with other specified complicationsHealth Condition 2: E116- Type 2 diabetes mellitus with other specified complications
- Registration Number
- CTRI/2019/09/021029
- Lead Sponsor
- Manipal Center for Infectious Diseases
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Both genders
2.Age 18 years or older
3.Patients with type 1 or 2 DM
4.Newly diagnosed foot ulcers
5.IDSA: uninfected. (For DFU patients)
6.IDSA: mild/moderate (For DFI patients)
7.Volunteers without a previous history of DM who has come for regular health check-up or blood donation (healthy controls)
8.Participants willing to give the informed consent form and participate in the study
1.Individuals with hepatic disease, renal disease, or other comorbidities that can alter vitamin D levels
2.Diagnosis of lower limb critical ischemia by Doppler ultrasound and ankle/arm index less than 0.5
3.Patients with lower limb ulcers with distal necrosis
4.Patients having clinical evidence of vascular insuf�ciency
5.Patients currently on steroid (use in the past 30 days) cytotoxic drugs, immunosuppressants, Calcium supplements, multivitamins, and drugs that could alter vitamin D status
6.Pregnant or breastfeeding women
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical Wound Healing <br/ ><br>Health Related Quality of Life (HRQoL)Timepoint: 4 months
- Secondary Outcome Measures
Name Time Method Quality of lifeTimepoint: 4 months