Topic Insulin Accelerates Wound Healing in Diabetes (insulin)
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | February 3, 2011 | ||||||||
| Last Updated Date | February 10, 2011 | ||||||||
| Start Date ICMJE | January 2004 | ||||||||
| Primary Completion Date | August 2007 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
% of Wound healing closing measured each week [ Time Frame: 7 days ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01295177 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Complete wound healing [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Topic Insulin Accelerates Wound Healing in Diabetes | ||||||||
| Official Title ICMJE | Topic Insulin Accelerates Wound in Diabetes | ||||||||
| 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 Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 Phase 2 |
||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
||||||||
| Condition ICMJE |
|
||||||||
| Intervention ICMJE | 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:
|
||||||||
| Study Arm (s) |
|
||||||||
| Publications * | Lima MH, Caricilli AM, de Abreu LL, Araújo EP, Pelegrinelli FF, Thirone AC, Tsukumo DM, Pessoa AF, dos Santos MF, de Moraes MA, Carvalheira JB, Velloso LA, Saad MJ. Topical insulin accelerates wound healing in diabetes by enhancing the AKT and ERK pathways: a double-blind placebo-controlled clinical trial. PLoS One. 2012;7(5):e36974. Epub 2012 May 25. | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 22 | ||||||||
| Completion Date | September 2007 | ||||||||
| Primary Completion Date | August 2007 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | 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 |
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Not Provided | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01295177 | ||||||||
| Other Study ID Numbers ICMJE | INSULIN22 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | mhmelolima@gmail.com, unicamp | ||||||||
| Study Sponsor ICMJE | University of Campinas, Brazil | ||||||||
| Collaborators ICMJE | Fundação de Amparo à Pesquisa do Estado de São Paulo | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | University of Campinas, Brazil | ||||||||
| Verification Date | February 2011 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||