Drug Treatment for Diabetic Foot.
Phase 4
- Conditions
- Health Condition 1: E112- Type 2 diabetes mellitus with kidney complications
- Registration Number
- CTRI/2021/02/031379
- Lead Sponsor
- PGIMER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Participants with any form of diabetes, age more than 18 years and with nephropathy defined as eGFR <60 ml/min/1.73 m2 (CKD-EPI equation) and /or presence of proteinuria defined as 24-hour urine albumin of 30-300 mg or macroalbuminuria 24-hour urine albumin of >300 mg and/or end stage kidney disease on maintenance dialysis or post renal transplant for DKD will be included.
Exclusion Criteria
Patients with active foot ulcer or who have received denosumab or any other anti-resorptive therapy in the prior six months, harboring an active malignancy, pregnant or lactating women will be excluded from the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome measure is the median time to clinical remission of CN in the two groups and proportion of patients who achieved clinical remission within six months of intervention.Timepoint: 24 week
- Secondary Outcome Measures
Name Time Method BTMs.Timepoint: 24 weeks.