Topic Insulin Accelerates Wound Healing in Diabetes

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

Detailed Description
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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

Official Title
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Topic Insulin Accelerates Wound in Diabetes

Conditions
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Diabetes Mellitus, Wounds

Intervention / Treatment
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* Drug: topic cream insulin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: vehicle cream<br>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<br>* 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.<br>* Other names: diabetes;|
| Placebo Comparator: cream insulin<br>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<br>* 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.<br>* Other names: diabetes;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of Wound healing closing measured each week |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete wound healing |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wound healing, diabetes mellitus