Intensive Versus Conventional Glycemic Control in Diabetic Foot Ulcer Healing (InVeCoG:DFU)

Post Graduate Institute of Medical Education and Research, Chandigarh

Status: Unknown

Conditions: Diabetic Foot Ulcer

Treatments: Drug: Insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT03740581

PGIMER ENDO

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Intensive

Active Comparator group

Description:

New anti-diabetic drug regimen with (mandatory) Insulin \>= 3 times per day

Treatment:

Drug: Insulin

Conventional

No Intervention group

Description:

Old anti-diabetic drug regimen with or without Insulin (\<3 times per day) to be continued as before