An open–label,single-centric, parallel group,randomized controlled trial to assess effectiveness and safety of topical insulin in wound healing

Topic: An open –label, single-centric, parallel group, randomized controlled trial to assess effectiveness and safety of topical insulin on wound healing

Aim: To assess effectiveness and safety of topical insulin on wound healing.

Objectives:

To study the effectiveness of topical insulin on wound healing.

To assess the safety of topical Insulin

To compare the topical insulin with normal saline in terms of efficacy and safety

STUDY DESIGN Open –label, single-centric, parallel group, randomized controlled trial

STUDY LOCATION This study will be done on patients visiting the OPD as well as the in-patients General Surgery of Teerthanker Mahaveer Medical College and Research Centre, Moradabad.

STUDY PERIOD This study will be conducted for ≃1.5 to 2 year after the approval from College Research Committee (CRC) and Institutional Ethical Committee (IEC)

Sample size: 41 in each group, 82 total

Inclusion criteria

Age18-65 years old

Either gender

Class 1 and 2 wound classifications as per CDC

Wound surface area 10 (less than 20cm2)

Patients willing to give informed consent

 Exclusion criteria

Pregnancy

Patients on immunosuppressive treatment

Wounds that are complicated (e.g., Bleeding or infection)

Medications that may impact the study’s outcome (NSAIDs etc.)

Cardiovascular illnesses, Peripheral artery disease or Renal and hepatic failure

 Treatment groups

Group A: insulin topical dressing

Group B: Normal saline topical dressing

 Effectiveness assessment

Wound area, depth and pace and amount of granulation tissue. Pain assessment measured at pre-determined time intervals

Safety Assessment

Blood glucose measurement and adverse drug reaction monitoring both spontaneous and checklist