Effects of Pulsatile Intravenous (IV) Insulin on Wound Healing in Diabetics (wounds)
|ClinicalTrials.gov Identifier: NCT00967837|
Recruitment Status : Terminated (Administrative)
First Posted : August 28, 2009
Last Update Posted : August 10, 2016
|Condition or disease||Intervention/treatment||Phase|
|Wound Healing Diabetes||Procedure: Pulsatile Intravenous Insulin Therapy||Phase 2 Phase 3|
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 (Clinical Trial)|
|Actual Enrollment :||152 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Pulsatile Intravenous Insulin Therapy on Diabetic Subjects With Non Healing Wounds|
|Study Start Date :||January 2006|
|Primary Completion Date :||January 2012|
|Study Completion Date :||September 2012|
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 Name: Humulin, Humulin R, Novolog
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00967837
|United States, Florida|
|Florida Atlantic University|
|Boca Raton, Florida, United States, 33487|
|Principal Investigator:||Betty Tuller, PhD||Florida Atlantic University|