Health Condition 1: E136- Other specified diabetes mellituswith other specified complications
Conditions
Interventions
Intervention1: Evaluation of growth factors and stemcell combination,novel formulation synergize to accelerate would healing in diabetic foot ulcer models: A growth factor and stem cell injection will
Sponsors
Chellaram Diabetes Research Center
Eligibility
Inclusion criteria
Inclusion criteria: 1. All subjects had DFUs with Wagner grades 2- 3 2. Ulcer with an area ranging from 1 cm2 to 60 cm2 will be included 3. Individuals with diabetes aged between 18 and 75 years 4. patients with the ankle-brachial index (ABI) (calculated using the highest ankle systolic pressure) of the affected limb greater than or equal to 0:5 and less than or equal to 1:3 will be enrolled.
Exclusion criteria
Exclusion criteria: 1. Patients with a significant acute cardio- cerebrovascular event within three months prior such as acute myocardial infarction and acute stroke 2. Presence of severe renal insufficiency (creatinine clearance <30 ml/min/1:73 m(2), 3. Presence of previously diagnosed or suspected malignancy 4. Corticosteroids and immunosuppressants use. 5. Malignant wounds 6. Presence of mental disability that compromises the therapeutic effect or accuracy of assessment. 7. Women who are planning to get pregnant during the study period or have already become pregnant 8. Sinus tracts that could not be removed by debridement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| re-epithelialisation rate (cm2/ week) and healing rate (%) potential outcome which will be calculated used for the assessment of the wounds.Timepoint: Baseline,1st week ,2nd week , 3rd week , 4th and 5th week. | — |
Secondary
| Measure | Time frame |
|---|---|
| nilTimepoint: nil | — |
Countries
India
Contacts
Public ContactDrChitra S
M.S Ramaiah Medical college and Hospital
Outcome results
None listed