Topic Insulin Accelerates Wound Healing in Diabetes
insulin
1 other identifier
interventional
22
0 countries
N/A
Brief Summary
The purpose of this study is to determine whether topic insulin is effective to accelerates wound healing in diabetes patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 diabetes-mellitus
Started Jan 2004
Longer than P75 for phase_1 diabetes-mellitus
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 3, 2011
CompletedFirst Posted
Study publicly available on registry
February 14, 2011
CompletedFebruary 14, 2011
February 1, 2011
3.6 years
February 3, 2011
February 10, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
% of Wound healing closing measured each week
7 days
Secondary Outcomes (1)
Complete wound healing
8 weeks
Study Arms (2)
vehicle cream
PLACEBO COMPARATORIntervention: 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
PLACEBO COMPARATORIntervention: 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Lima MH, Caricilli AM, de Abreu LL, Araujo 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. doi: 10.1371/journal.pone.0036974. Epub 2012 May 25.
PMID: 22662132DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Maria Helena M Lima, PhD
University of Campinas (UNICAMP)
- PRINCIPAL INVESTIGATOR
Mario J Saad, MD PhD
University of Campinas (UNICAMP)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 3, 2011
First Posted
February 14, 2011
Study Start
January 1, 2004
Primary Completion
August 1, 2007
Study Completion
September 1, 2007
Last Updated
February 14, 2011
Record last verified: 2011-02