Status:
UNKNOWN
Intensive Glycemic Control For Diabetic Foot Ulcer Healing
Lead Sponsor:
Post Graduate Institute of Medical Education and Research, Chandigarh
Collaborating Sponsors:
Institute of Post-Graduate Medical Education and Research, Kolkata
Jawaharlal Institute of Postgraduate Medical Education & Research
Conditions:
Diabetic Foot Ulcer
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
With the available molecular and cellular evidence of impaired wound healing due to hyperglycemia, investigators postulate hypothesis asking whether intensive glycemic control could improve diabetic f...
Detailed Description
BURDEN OF DIABETIC FOOT According to International Diabetic Federation, there will be over 642 million people with diabetes in the world by 2040.Diabetic Foot Ulcer (DFU) is one of the most serious, m...
Eligibility Criteria
Inclusion
- Age \>18 years
- Patients of DM according to ADA guidelines
- HbA1c \>8% (single occasion at screening) and/or FBG \>130 on 3 consecutive occasions
- DFU: Wagner grade 1, 2 \& 3 or UTS 1, 2-3B
- Duration of ulcer\>2 weeks
- Wound size: \>1cm2
- Willingness to sign consent form \& participate in the study
- Capacity to attend visits at hospital for review
Exclusion
- Diagnosis with unpredictable healing ability e.g. malignancy, depression, HIV, CTD, steroid use
- Dialysis requiring CKD \& eGFR \<30 ml/min
- Anemia with hemoglobin \<10 gm/dl
- Active Charcot foot
- PEDIS 4: life threatening DFU
- Pregnancy
- ABI \<0.7
- Refusal to give informed consent
Key Trial Info
Start Date :
October 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
326 Patients enrolled
Trial Details
Trial ID
NCT04323462
Start Date
October 1 2021
End Date
December 1 2022
Last Update
November 2 2021
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
IPGMER
Kolkata, West Bengal, India, 189212
2
Deptt of Endocrinology
Chandigarh, India, 160012