Effects of Pulsatile Intravenous (IV) Insulin on Wound Healing in Diabetics (wounds)

August 8, 2016 updated by: Florida Atlantic University

Effects of Pulsatile Intravenous Insulin Therapy on Diabetic Subjects With Non Healing Wounds

One of the significant complications associated with some patients with diabetes is the inability for wounds to heal regardless of enrolling and participating in a traditional wound healing program. There have been a number of anecdotal evidence presented by patients receiving pulsatile intravenous insulin therapy for other complications with non healing wounds lasting from several months to several years whose wounds healed while receiving therapy. This study was designed to specifically monitor the progress of diabetic patients who have failed traditional wound care therapy and monitor the progress of their wounds while receiving pulsatile intravenous insulin therapy.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Diabetes can produce complications including the inability for wounds to heal despite participating in a traditional wound care therapy program.

At times of reduced tissue oxygen, such as when circulation is decreased, there is anecdotal evidence that pulsed IV insulin (by enabling the production of energy from glucose) may permit heart, skeletal muscle, skin, and other organs to function more normally and even to repair damage and heal. By tracking the progress in diabetic patients that have failed traditional wound care therapy who are monitored by their podiatrist or other health care professional to objectively determine the effect of pulsatile IV therapy on the rate of healing.

Independent evaluation of the wound is provided including visual examination, pictures and measurements on a weekly to bi-weekly basis.

Individuals breathe into a mask for 3-5 minutes after a rest period of 30 or more minutes. The ratio of exhaled volume of CO2 to the inhaled volume of O2 is determined as the RQ. The physiologic range is 0.7 to1.3. Individuals using fat as a primary fuel have a ratio of 0.7, protein or mixed fuels is 0.8-0.9 and carbohydrate is 0.9-1.0. Those taking excessive calories will have RQ's higher than 1.05. The RQ can be followed serially and this is done before and after each pulsatile IV insulin treatment, during the 3 successive sessions on a single treatment day. The amount of intravenous insulin and oral glucose given is determined by the RQ changes during the previous session. Pulsatile IV insulin therapy encourages the glucose metabolism in diabetics to normalize in multiple organs, especially muscle, retina, liver, kidney and nerve endings. The process fundamentally requires the administration of high dose insulin pulses similar to those found in non diabetic humans by their pancreas into the surrounding portal circulation. Oral carbohydrates are given simultaneously to augment the process and prevent hypoglycemia. The process is monitored by frequent glucose levels and respiratory quotients (RQ). RQ is measured by a metabolic cart which determines the ratio VCO2/ VO2. This ratio is specific for the fuel used at any one time by the body. The glucose levels are monitored to keep glucose levels appropriate and the RQ determines the need to readjust the infusion protocol in each patient for subsequent insulin infusion sessions.Patient is evaluated post session and discharged when stable.

Frequent monitoring of RQ is necessary as these levels change rapidly, depending on the fuel being utilized by the body. Pulsatile IV insulin therapy shifts metabolism from primarily fatty acid metabolism to primarily glucose metabolism. This shift is reflected by the increase in respiratory quotient. However during rest periods the RQ may fall back to lower levels. Therefore RQ's are done at the beginning and at the end of each insulin infusion session of 1 hour in order to appropriately monitor and adjust insulin and carbohydrate loads to reach optimal activation in each session

Study Type

Interventional

Enrollment (Actual)

152

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Boca Raton, Florida, United States, 33487
        • Florida Atlantic University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diagnosed with type 1 or type 2 diabetes
  • taking oral and/or insulin for diabetes control
  • endocrinologist must assess and approve pt for participation in study
  • ability to swallow without difficulty
  • ability to meet weekly time and testing requirements for this study

Exclusion Criteria:

  • inability to do testing required for study including regular scheduled visits for independent review of non healing wound including assessment, pictures and measurements
  • lack of intravenous access
  • alcohol abuse, drug addiction or the use of illegal drugs
  • positive HIV
  • active liver disease
  • in active treatment for cancer including radiation or chemotherapy
  • inability to breathe into machine for respiratory quotients to monitor progress

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diabetes with non healing wounds
To determine and monitor progress of diabetic patients with non healing wounds that have failed conventional 60 day treatment respond to pulsatile intravenous insulin therapy in improving and completing healing in non healing wounds
Procedure: Pulsatile Intravenous Insulin Therapy
Diabetic pts that meet trial criteria referred by an endocrinologist are given Pulsatile intravenous insulin therapy on a weekly basis. Weekly orders for insulin dosage is based upon pt response to therapy monitored by RQ and insulin resistance.
Other Names:
  • Humulin, Humulin R, Novolog

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To measure progress of wound healing in subjects that have failed conventional wound care healing treatments for 60 days
Time Frame: Monitoring of wound is done at baseline and weekly follow up visits including visual examination, pictures of wound and measurements
Monitoring of wound is done at baseline and weekly follow up visits including visual examination, pictures of wound and measurements

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Florida Atlantic University

Collaborators

Advanced Diabetes Treatment Centers

Investigators

  • Principal Investigator: Betty Tuller, PhD, Florida Atlantic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

August 6, 2009

First Submitted That Met QC Criteria

August 27, 2009

First Posted (Estimate)

August 28, 2009

Study Record Updates

Last Update Posted (Estimate)

August 10, 2016

Last Update Submitted That Met QC Criteria

August 8, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H09-66

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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