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Topic Insulin Accelerates Wound Healing in Diabetes (insulin)

Primary Purpose

Diabetes Mellitus, Wounds

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
topic cream insulin
Sponsored by
University of Campinas, Brazil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring wound healing, diabetes mellitus

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Placebo Comparator

    Arm Label

    vehicle cream

    cream insulin

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    % of Wound healing closing measured each week

    Secondary Outcome Measures

    Complete wound healing

    Full Information

    First Posted
    February 3, 2011
    Last Updated
    February 10, 2011
    Sponsor
    University of Campinas, Brazil
    Collaborators
    Fundação de Amparo à Pesquisa do Estado de São Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01295177
    Brief Title
    Topic Insulin Accelerates Wound Healing in Diabetes
    Acronym
    insulin
    Official Title
    Topic Insulin Accelerates Wound in Diabetes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2004 (undefined)
    Primary Completion Date
    August 2007 (Actual)
    Study Completion Date
    September 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Campinas, Brazil
    Collaborators
    Fundação de Amparo à Pesquisa do Estado de São Paulo

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Wounds
    Keywords
    wound healing, diabetes mellitus

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    22 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    vehicle cream
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Arm Title
    cream insulin
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    topic cream insulin
    Other Intervention Name(s)
    wound healing, insulin cream, diabetes
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    % of Wound healing closing measured each week
    Time Frame
    7 days
    Secondary Outcome Measure Information:
    Title
    Complete wound healing
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Maria Helena M Lima, PhD
    Organizational Affiliation
    University of Campinas (UNICAMP)
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Mario J Saad, MD PhD
    Organizational Affiliation
    University of Campinas (UNICAMP)
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22662132
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

    Topic Insulin Accelerates Wound Healing in Diabetes

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