Effect of Insulin on Wound Healing-A Randomized Controlled Trial

Ministry of Health, Bahrain

Status and phase: Unknown; Phase 4

Conditions: Wound Heal

Treatments: Drug: Insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT04390815

IWCT20

Details and patient eligibility

About

A randomized controlled trial examining the effect of insulin on wound healing in both diabetics and non diabetic patients in a local health center in Bahrain.

Full description

This is a double blinded RCT comparing the effect of insulin on wound healing in both diabetics and non diabetics.

The study will run in primary care setting in Bahrain. The aim of this study is to heal wound in an innovative way. and the Objective: to evaluate the effect of topical insulin administration on wound healing.

All adult patients with skin wounds attending primary health care center will be included in the study. Patients with acute and chronic wounds of the upper and lower extremities will be eligible to participate.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Adult patients with Texas 1 and 2 wound criteria

Exclusion Criteria: Texas 3 and 4 wound criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

Before starting the therapeutic procedure, all wounds will be fully washed with normal saline. Group A patients will receive 10 units (0.1 mL) of regular insulin (manufactured by novo nordisk) in solution with 1 cc of normal saline 0.9% for each 10 cm of wound. The solution will be sprayed on the wound surface with an insulin syringe needle, once daily. The patients in this arm will receive conventional therapy.

Treatment:

Drug: Insulin

Control

Placebo Comparator group

Description:

Before starting the therapeutic procedure, all wounds will be fully washed with normal saline Group B patients will receive conventional topical application without insulin

Treatment:

Drug: Insulin