Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
Conditions
Interventions
Intervention1: Subcutaneous Darbepoetin Alfa: Participants will receive subcutaneous darbepoetin alfa, 25 micrograms once weekly for 12 weeks, in addition to standard care including wound management,
Sponsors
syed nilufar
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosed with Diabetes mellitus type -2 Presence of Wagner grade 1 or grade 2-foot ulcer
Exclusion criteria
Exclusion criteria: Active osteomyelitis or a history of osteomyelitis resolved within the last 4 weeks Presence of active gangrene at the time of screening History of solid tumors within the past 5 years History of hematological malignancies within the past 2 years Prior use of erythropoiesis-stimulating agents within the last 3 months Any history of pure red cell aplasia History of thromboembolic events within the past 6 months History of stroke or transient ischemic attack within the past 6 months Uncontrolled hypertension, defined as systolic greater than 160 mm hg or diastolic greater than 100 mm hg on atleast two readings taken one week apart Baseline hemoglobin concentration greater than 13mg per dl Pregnant women Lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in wound size from baseline through weeks 4, 8, and 12, measured using the manual length-width method in centimetersTimepoint: weeks 4, 8, and 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events related to darbepoetin alfa or standard careTimepoint: Throughout study, baseline to week 12;Change in HbA1c from baseline to end of treatment at 12 weeksTimepoint: Baseline, Week 12;Change in haemoglobin levels in intervention group, measured at screening, weeks 2, 4, 6, 8, 10, and 12Timepoint: Screening, Week 2, 4, 6, 8, 10, 12 ;Change in granulation tissue formation at baseline, week 4, 8, and 12Timepoint: Baseline, Week 4, Week 8, Week 12 | — |
Countries
India
Contacts
Public ContactDR S Seethalakshmi
ESIC Medical college and hospital
Outcome results
None listed