An interventional study of Insulin in Diabetic Foot Ulcer, sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh. Status unknown at 1 site in India. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2018-11-14.
Sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh · Not applicable, Interventional, and Treatment
Diabetic foot ulcer is one of the most serious, most costly and at times life threatening complication of diabetes. The lifetime incidence of foot ulcer occurrence in diabetes is up to 25%. Despite the advent of numerous types of wound dressings and off-loading mechanisms, the ulcer healing rates in diabetes have remained dismally low. Hyperglycemia impairs the inflammatory, proliferative and remodeling phases of an ulcer. There are retrospective studies linking improvement of HbA1c to wound area healing rate. The investigators hypothesised that intensive glycemic control in a patient of diabetic foot ulcer improves the healing process. To explore this hypothesis, the investigators are conducting this randomized control trial with the primary aim of wound healing in patients of diabetic foot ulcer on either intensive glycemic treatment or conventional (pre-existing) glycemic treatment.
1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 826 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Post Graduate Institute of Medical Education and Research, Chandigarh is the lead sponsor of 290 studies on the registry; 42 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
New anti-diabetic drug regimen with (mandatory) Insulin \>= 3 times per day
Drug: Insulin
Old anti-diabetic drug regimen with or without Insulin (\<3 times per day) to be continued as before
Basal Bolus regimen (Participant to receive, Insulin \>= 3 times per day)
Number of participants with complete wound closure (epithelialisation) at 12 weeks in both intensive and conventional treatment groups.
Ulcer area to be measured by Wound Measurement Camera model WZ2.0 (bought from (Wound zoom incorporate, 2916, Borham Ave, Stevens Point, W1, USA 54481) at baseline, 4 and 12 weeks.
Time frame: 12 weeks
Percent reduction in ulcer area (from baseline) at 4 & 12 weeks in both intensive and conventional treatment groups.
This will be calculated using the measured ulcer area for all participants, irrespective of wound closure status.
Time frame: 4 and 12 weeks
HbA1c at 4 & 12 weeks in both intensive and conventional groups.
This ill be done to correlate glycemic control with ulcer area at 4 and 12 weeks respectively.
Time frame: 4 and 12 weeks
Change in ulcer severity- Wagner and UTWSC classification.
Downgrade of ulcer severity based on two well established diabetic foot ulcer classification systems and there correlation with wound closure and glycemic control will be seen.
Time frame: 4 and 12 weeks
Incidence of any amputation.
This outcome to be correlated with the glycemic control in both the groups.
Time frame: 4 and 12 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Post Graduate Institute of Medical Education and Research, Chandigarh