Effects of Local Insulin on Wound Angiogenesis

Angiogenesis Clinical Trial

Official title:

Effects of Local Insulin on Angiogenesis in Acute Wounds in Non-diabetic Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02396888
• Other study ID #: 71-13
• Status: Active, not recruiting
• Phase: Phase 3
• First received: March 6, 2015
• Last updated: March 18, 2015
• Start date: October 2014
• Est. completion date: May 2015

Study information

• Verified date: March 2015
• Source: Hospital Central "Dr. Ignacio Morones Prieto"
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Secretaria de Salud
• Study type: Interventional

Clinical Trial Summary

Randomized, split plot, double-blind, placebo controlled trial. Half of the wounds surface was applied daily with insulin and the other half with saline solution as placebo. Biopsy specimens of the two sides were obtained on days 0 and 14. Number of blood vessels will be evaluated as main outcome.

Description:

Randomized, split plot, double-blind, placebo controlled trial. Non-diabetic patients with full-thickness wounds will be treated in the following manner: in half of the surface insulin will be applied in a daily basis, on the other half, saline solution will be used as placebo. Biopsy specimens of both sides will be obtained on days 0 and 14. Number of blood vessels will be evaluated as main outcome.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: May 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Nondiabetic patients with full-thickness acute wounds

Exclusion Criteria:

• Diabetic patients

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angiogenesis

Intervention

Drug:
• Insulin
Half of the wound surface was treated daily with 10 units of intermediate insulin.
• Placebo
Half of the wound surface was treated daily with 0.1 cc of normal saline.

Locations

Country	Name	City	State
Mexico	Hospital Central Dr. Ignacio Morones Prieto	San Luis Potosí

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Central "Dr. Ignacio Morones Prieto"	Universidad Autonoma de San Luis Potosí

Country where clinical trial is conducted

Mexico, 

References & Publications (1)

Martínez-Jiménez MA, Aguilar-García J, Valdés-Rodríguez R, Metlich-Medlich MA, Dietsch LJ, Gaitán-Gaona FI, Kolosovas-Machuca ES, González FJ, Sánchez-Aguilar JM. Local use of insulin in wounds of diabetic patients: higher temperature, fibrosis, and angio — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of blood vessels	In a biopsy taken at baseline, blood vessels will be counted	14 days	No
Secondary	Hypoglycaemia	Presence of capillary blood glucose of <60 mg/dl	14 days	Yes