Diabetic Foot Ulcers, Dressing, Insulin, Topical
Conditions
Brief summary
This study aimed to find out the advantages of topical insulin in the management of diabetic foot ulcers over the conventional wound saline dressing.
Detailed description
Non healing foot ulcers constitute a major problem that plagues those with diabetes due to angiopathy and neuropathy. It is well known that the basic cellular and molecular mechanisms that result in wound healing involve cell adhesion, migration, proliferation, differentiation, and apoptosis. The molecular mechanisms of insulin signaling and its metabolic effects have been well studied in its classical target tissues. Insulin stimulates the growth and development of different cell types and affects proliferation, migration, and secretion by keratinocytes, endothelial cells, and fibroblasts.
Interventions
DRUGInsulin
The ulcers were cleaned with normal saline and then irrigated with 4 units (0.1 ml) of human soluble insulin (Actrapid) in 1 ml normal saline (0.9%) for every 10 cm square of the wound.
DRUGNormal saline
The ulcers were cleaned with normal saline without insulin and covered with sterile cotton gauzes
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients with diabetes between the age group 18-85 years. * Both sexes. * Patients who were diagnosed with diabetic foot according to the 2010 Edition of the Clinical Practice Guidelines for the Prevention and Management of Diabetes Foot Complications (edited by the American Diabetes Association) presented to diabetic foot clinic on regular basis. * Participants who were able to and willing to participate in the study voluntarily who could come for dressings on a daily basis, or patients who agreed for admission for the duration of treatment were included in the study. * Patients having ulcer below the ankle on the dorsal or plantar aspect of the foot. * Patients with grade I and grade II ulcers of Wegener's Classification without significant growth of granulation tissue. * Patients with controlled blood glucose levels between 110 and 130 gm/dl. Hemoglobin A1c was 7.1 ± 0.34. * Non heavely infected wounds without significant growth of granulation tissue.
Exclusion criteria
* Patients with diabetic foot ulcers of Wagner grade V. * X-ray showing features of osteomyelitis. * Duplex showing significant atherosclerotic changes and venous abnormalities like varicosities. * Malnutrition and uncontrolled diabetes mellitus. * Other clinically significant medical conditions that would impair wound healing like any hepatic, renal, immunological and neurological disease and coagulopathy. * Patients receiving corticosteroids, other immunosuppressive agents, radiation or chemotherapy one month prior to entry into the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of diabetic foot ulcer healing | 12 weeks after the treatment | Rate of diabetic foot ulcer healing was recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need for surgical debridement | 12 weeks after the treatment | The need for surgical debridement was recorded. |
Countries
Egypt
Outcome results
None listed