Diabetic Foot Ulcer
Conditions
Keywords
Diabetic foot ulcer, Intensive glycemic control
Brief summary
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.
Interventions
DRUGInsulin
Basal Bolus regimen (Participant to receive, Insulin \>= 3 times per day)
Sponsors
Post Graduate Institute of Medical Education and Research, Chandigarh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \>18 years 2. Patients of DM according to ADA guidelines 3. HbA1c \>8% and/or FBG \>130 on 3 consecutive occasions 4. DFU: Wagner grade 2 & 3 or UTS 2-3B 5. Duration of ulcer \<12 weeks 6. Wound size: \>1cm2 7. Willingness to sign consent form & participate in the study 8. Capacity to attend visits at hospital for review
Exclusion criteria
1. Diagnosis with unpredictable healing ability e.g. malignancy, depression, HIV, CTD, steroid use 2. Dialysis requiring CKD & eGFR \<30 ml/min 3. Active Charcot foot 4. PEDIS 4: life threatening DFU 5. Pregnancy 6. ABI \<= 0.7 7. Refusal to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with complete wound closure (epithelialisation) at 12 weeks in both intensive and conventional treatment groups. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent reduction in ulcer area (from baseline) at 4 & 12 weeks in both intensive and conventional treatment groups. | 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. | 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. | 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. | 4 and 12 weeks | This outcome to be correlated with the glycemic control in both the groups. |
Countries
India
Contacts
Primary ContactAditya Dutta, MD
Backup ContactAshu Rastogi, MD, DM
Outcome results
None listed