Angiogenesis, Chronic Venous Disease, Insulin, Varicose Ulcer, Wound Healing
Conditions
Keywords
Varicose Ulcer, Wound Healing, Insulin, Angiogenesis
Brief summary
A randomized, split-plot, double-blind, placebo-controlled trial. The varicose ulcer is divided into two (side A and B). Half of the wound's surface is treated locally with insulin (Glargine) applied at an approx depth of 3-4 mm. Treatment with insulin is administered for 7 days. Biopsy specimens of the two sides are obtained on days 0 and 7. A thermographic photograph of the wound is taken at days 0 and 7. The number of blood vessels and fibroplasia is evaluated as the main outcome.
Detailed description
A randomized, split-plot, double-blind, placebo-controlled trial. Chronic Varicose Ulcers measuring more than 4 cm in any of its dimensions, and that comply with candidate criteria are included in the present study. A split-mouth model is used. The ulcer is divided into two (sides A and B). The side in which treatment is applied is randomized. Half of the wound's surface is treated locally with insulin (Glargine) applied at an approx depth of 3-4 mm. Both halves are covered with dressings and compression therapy is applied. Treatment with insulin is administered for 7 days. Biopsy specimens of the two sides are obtained on days 0 and 7. A thermographic photograph of the wound is taken at days 0 and 7, as control of the local temperature of the wound. This is to asses the process of healing and to correlate with our outcome measures. The number of blood vessels will be evaluated as the main outcome. Fibroplasia and thermal asymmetry between wound sides will be evaluated as secondary outcomes.
Interventions
DRUGInsulin Glargine
Half of the wound surface is injected daily with topical glargine insulin
DRUGSaline
Half of the wound surface is injected daily with topical saline solution
Sponsors
Hospital Central Dr. Ignacio Morones Prieto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double (Participant, Investigator) Double Blind (Participant, Investigator)
Intervention model description
Parallel assignment Randomized split-plot design
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Any gender * Presence of varicose ulcer in lower extremities with a size greater than 25 cm2 * Absence of infection
Exclusion criteria
* Presence of diabetes or glycated hemoglobin \>6.5% * Comorbidities that affect wound healing * Malnutrition * Active smoking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Final angiogenesis | Day 7 | Number of blood vessels in a skin biopsy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fibroplasia | Day 7 | Percentage of fibrous tissue in a skin biopsy |
| Thermal asymmetry | Day 7 | Difference between the temperature of the wound and the surrounding healthy tissue |
| Hypoglycaemia | Day 7 | Presence of capillary blood glucose of \<60 mg/dl or clinical symptoms of hypoglycemia |
Countries
Mexico
Outcome results
None listed