Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT05444842 |
Other study ID # |
p.t.REC/012/003670 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
July 5, 2022 |
Est. completion date |
November 30, 2022 |
Study information
Verified date |
July 2022 |
Source |
Cairo University |
Contact |
al shaymaa sh abd el azeim, lecturer |
Phone |
01033771553 |
Email |
alshaymaa.shaaban[@]pt.cu.edu.eg |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This study will be conducted to investigate the effect of Insulin iontophoresis mixed with
oleic acid versus topical insulin in patients with chronic diabetic foot ulcer
Description:
Despite insulin treatment and a meticulously controlled diet, approximately 15% of all
patients with diabetes will, at some time, have non-healing wounds and this is the leading
cause of lower extremity amputation. Wound healing involves cell adhesion, migration,
proliferation, differentiation, and apoptosis at cellular and molecular levels. Abnormalities
of distinct factors of wound healing contribute to defective wound healing in diabetes
ulcers, including decreased growth factor production, angiogenic response, macrophage
function, collagen accumulation, epidermal barrier.
Insulin has great effect on ulcers healing and tissue regeneration but there is a catch that
insulin is a large polymer that have difficulty crossing skin barrier but with using
penetration enhancers like oleic acid combined with iontophoresis helps insulin to get
through skin especially that affect locally on wound not systematic. Insulin help in
restoring the function and structure of the vasculature and improving angiogenesis, reduces
the local wound blood glucose concentration, thus reducing the damage resulting from the
accumulation of high levels of glucose metabolic intermediates, insulin is the inhibitor of
three major proinflammatory transcription factors: Nuclear factor-κB, activator protein-1 and
early growth response-1 (EGR-1). insulin relieves the inflammatory response and prevents an
excessive inflammatory reaction. Furthermore, insulin inhibits the degradation of immune cell
proteins, thus enhancing immune activity. 45 patients with diabetic feet will be assigned
randomly into 3 equal group; group A will receive insulin iontophoresis for 13 sessions,
group B will receive topical insulin and group C will receive saline dressing for 13 weeks