Intensive Versus Conventional Glycemic Control in Diabetic Foot Ulcer Healing (InVeCoG:DFU)
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|ClinicalTrials.gov Identifier: NCT03740581|
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : November 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Foot Ulcer||Drug: Insulin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Intensive Versus Conventional Glycemic Control in Diabetic Foot Ulcer Healing: a Randomised Control Trial|
|Actual Study Start Date :||November 1, 2017|
|Estimated Primary Completion Date :||June 30, 2019|
|Estimated Study Completion Date :||June 30, 2019|
Active Comparator: Intensive
New anti-diabetic drug regimen with (mandatory) Insulin >= 3 times per day
Basal Bolus regimen (Participant to receive, Insulin >= 3 times per day)
No Intervention: Conventional
Old anti-diabetic drug regimen with or without Insulin (<3 times per day) to be continued as before
- Number of participants with complete wound closure (epithelialisation) at 12 weeks in both intensive and conventional treatment groups. [ Time Frame: 12 weeks ]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.
- Percent reduction in ulcer area (from baseline) at 4 & 12 weeks in both intensive and conventional treatment groups. [ Time Frame: 4 and 12 weeks ]This will be calculated using the measured ulcer area for all participants, irrespective of wound closure status.
- HbA1c at 4 & 12 weeks in both intensive and conventional groups. [ Time Frame: 4 and 12 weeks ]This ill be done to correlate glycemic control with ulcer area at 4 and 12 weeks respectively.
- Change in ulcer severity- Wagner and UTWSC classification. [ Time Frame: 4 and 12 weeks ]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.
- Incidence of any amputation. [ Time Frame: 4 and 12 weeks ]This outcome to be correlated with the glycemic control in both the groups.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03740581
|Contact: Aditya Dutta, MDfirstname.lastname@example.org|
|Contact: Ashu Rastogi, MD, DMemail@example.com|
|Postgraduate Medical Institute of Medical Education and Research||Recruiting|
|Chandigarh, India, 160012|
|Contact: Aditya Dutta, MD +919818892996 firstname.lastname@example.org|
|Contact: Ashu Rastogi, MD, DM +919781001046 email@example.com|
|Sub-Investigator: Anil Bhansali, MD, DM|