Topic Insulin Accelerates Wound Healing in Diabetes

Phase 1

Completed

• Conditions: Diabetes Mellitus; Wounds
• Interventions: Drug: topic cream insulin

• Registration Number: NCT01295177
• Lead Sponsor: University of Campinas, Brazil

Brief Summary

The purpose of this study is to determine whether topic insulin is effective to accelerates wound healing in diabetes patients

Detailed Description

Wound healing is impaired in diabetes mellitus, but the mechanisms involved are not well established. The purpose of this study was to investigate the effect of a topic insulin cream on wound healing in diabetic patients. age eligible for study:18 years old-older gender eligible for study:both accepts healthy volunteers:no have a proband with T1DM or T2DM. A proband is an individual with more than one year of diagnosis.

have proband with a wound that is difficult to be healed for at least three months.

patients with serum creatinine \<1.5mg/dl Does not satisfy the above inclusion criteria infection diagnosed wound patients with cellulitis, venous stasis, inadequate perfusion, osteomyelitis and patient's inability to attend clinics for follow up

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2007-08
• Study Completion: 2007-09
• Status Verified: 2011-02
• Study First Submitted: 2011-02-03
• Study First Submitted QC: 2011-02-10
• Last Update Submitted: 2011-02-10
• Study First Posted: 2011-02-14
• Last Update Posted: 2011-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

age eligible for study:18 years old-older gender eligible for study:both accepts healthy volunteers:no have a proband with T1DM or T2DM. A proband is an individual with more than one year of diagnosis. have proband with a wound that is difficult to be healed for at least three months.

patients with serum creatinine <1.5mg/dl

Exclusion Criteria

Does not satisfy the above inclusion criteria infection diagnosed wound patients with cellulitis, venous stasis, inadequate perfusion, osteomyelitis and patient's inability to attend clinics for follow up

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vehicle cream	topic cream insulin	Intervention: Placebo cream vehicle. Patients with wounds for more than 3 months without infection. These patients were treated with placebo cream (cream with the same constitution but without insulin). The placebo cream vehicle was used for 8 weeks.
cream insulin	topic cream insulin	Intervention: insulin cream. Patients with wounds for more than 3 months without infection. These patients were treated with insulin cream (cream with the same constitution but with insulin). The insulin cream was used for 8 weeks.

Primary Outcome Measures

Name	Time	Method
% of Wound healing closing measured each week	7 days

Secondary Outcome Measures

Name	Time	Method
Complete wound healing	8 weeks