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Topic Insulin Accelerates Wound Healing in Diabetes (insulin)

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Campinas, Brazil
ClinicalTrials.gov Identifier:
NCT01295177
First received: February 3, 2011
Last updated: February 10, 2011
Last verified: February 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus
Wounds
 Drug: topic cream insulin
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Topic Insulin Accelerates Wound in Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Campinas, Brazil:

Primary Outcome Measures:
  • % of Wound healing closing measured each week [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Complete wound healing [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 22
Study Start Date: January 2004
Study Completion Date: September 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01295177

Sponsors and Collaborators
University of Campinas, Brazil
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Study Chair: Maria Helena M Lima, PhD University of Campinas (UNICAMP)
Principal Investigator: Mario J Saad, MD PhD University of Campinas (UNICAMP)
  More Information

No publications provided by University of Campinas, Brazil

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: mhmelolima@gmail.com, unicamp
ClinicalTrials.gov Identifier: NCT01295177     History of Changes
Other Study ID Numbers: INSULIN22
Study First Received: February 3, 2011
Last Updated: February 10, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Campinas, Brazil:
wound healing
diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013