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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive | Active Comparator | New anti-diabetic drug regimen with (mandatory) Insulin >= 3 times per day |
|
| Conventional | No Intervention | Old anti-diabetic drug regimen with or without Insulin (<3 times per day) to be continued as before |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin | Drug | Basal Bolus regimen (Participant to receive, Insulin >= 3 times per day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 and 12 weeks |
| HbA1c at 4 & 12 weeks in both intensive and conventional groups. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aditya Dutta, MD | Contact | +919818892996 | addiedutta05@gmail.com | |
| Ashu Rastogi, MD, DM | Contact | +919781001046 | ashuendo@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Postgraduate Medical Institute of Medical Education and Research | Recruiting | Chandigarh | 160012 | India |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 25, 2020 | |
| Reset | Apr 8, 2020 | |
| Release | Apr 10, 2020 | |
| Reset | Apr 21, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 25, 2020 | Apr 8, 2020 | |||
| Apr 10, 2020 |
| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| ID | Term |
|---|---|
| D007328 | Insulin |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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This ill be done to correlate glycemic control with ulcer area at 4 and 12 weeks respectively. |
| 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. | 4 and 12 weeks |
| Incidence of any amputation. | This outcome to be correlated with the glycemic control in both the groups. | 4 and 12 weeks |
| Apr 21, 2020 |
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |