insulin: Topic Insulin Accelerates Wound Healing in Diabetes

Sponsor

University of Campinas, Brazil (Other)

Overall Status

Completed

CT.gov ID

NCT01295177

Collaborator

Fundação de Amparo à Pesquisa do Estado de São Paulo (Other)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus Wounds	Drug: topic cream insulin	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Topic Insulin Accelerates Wound in Diabetes

Study Start Date :

Jan 1, 2004

Actual Primary Completion Date :

Aug 1, 2007

Actual Study Completion Date :

Sep 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: vehicle cream 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.	Drug: topic cream insulin Intervention: Placebo cream versus insulin cream. Patients with wounds for more than 3 months without infection. These patients were treated with placebo cream or insulin cream. The placebo or insulin were used for 8 weeks. Other Names: wound healing insulin cream diabetes
Placebo Comparator: 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.	Drug: topic cream insulin Intervention: Placebo cream versus insulin cream. Patients with wounds for more than 3 months without infection. These patients were treated with placebo cream or insulin cream. The placebo or insulin were used for 8 weeks. Other Names: wound healing insulin cream diabetes

Arm

Intervention/Treatment

Placebo Comparator: vehicle cream

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.

Drug: topic cream insulin

Intervention: Placebo cream versus insulin cream. Patients with wounds for more than 3 months without infection. These patients were treated with placebo cream or insulin cream. The placebo or insulin were used for 8 weeks.

Other Names:

wound healing

insulin cream

diabetes

Placebo Comparator: 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.

Drug: topic cream insulin

Other Names:

wound healing

insulin cream

diabetes

Outcome Measures

Primary Outcome Measures

% of Wound healing closing measured each week [7 days]

Secondary Outcome Measures

Complete wound healing [8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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