Wound HealingPhase 2/3woundsNCT00967837
Effects of Pulsatile Intravenous (IV) Insulin on Wound Healing in Diabetics
A Phase 2/3 study testing Pulsatile Intravenous Insulin Therapy in people with Wound Healing and Diabetes, run by Florida Atlantic University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Healing, Diabetes
- What is being tested?
- Pulsatile Intravenous Insulin Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Sep 2012
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida Atlantic University
Boca Raton, Florida, 33487
About this study
Official title: 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.
Read the 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
- Conditions
- Wound Healing, Diabetes
- Being tested
- Pulsatile Intravenous Insulin Therapy
- Keywords
- Diabetes with complications, Wound healing
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsatile Intravenous Insulin TherapyProcedure or surgery
Also called Humulin, Humulin R, Novolog
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.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes with non healing wounds | Experimental | 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 Receives: Procedure: Pulsatile Intravenous Insulin Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure progress of wound healing in subjects that have failed conventional wound care healing treatments for 60 days
Measured: Monitoring of wound is done at baseline and weekly follow up visits including visual examination, pictures of wound and measurements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2009 (estimated)
- Study startJan 2006
- Primary completionJan 2012
- Study completionSep 2012
Why it stopped: Administrative
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida Atlantic University
- Sponsor type
- University, hospital or other
- Collaborators
- Advanced Diabetes Treatment Centers
- Responsible party
- Sponsor
- Investigators
- Betty Tuller, PhD, Principal investigator, Florida Atlantic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00967837
- Sponsor's protocol ID
- H09-66
- Acronym
- wounds
- Status last verified
- Aug 2016
- First submitted
- 6 Aug 2009
- Last updated
- 10 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pulsatile Intravenous Insulin Therapy on Diabetic Subjects With Non Healing Wounds
- ClinicalTrials.gov ID
- NCT00967837
- Acronym / sponsor ID
- wounds / H09-66
- Conditions
- Wound Healing, Diabetes
- Keywords
- Diabetes with complications, Wound healing
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Administrative
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Florida Atlantic UniversityUniversity, hospital or other
- Collaborators
- Advanced Diabetes Treatment Centers
- Study start
- Jan 2006
- Primary completion
- Jan 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 28 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetes with non healing wounds | Experimental | Procedure: Pulsatile Intravenous Insulin TherapyTo 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsatile Intravenous Insulin TherapyAlso: Humulin, Humulin R, NovologDiabetic 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. | Procedure or surgery | Diabetes with non healing wounds |
Primary outcome
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
Results and safety
The study was stopped early (reason given: Administrative). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Betty Tuller, PhD principal investigator
Florida Atlantic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Pulsatile Intravenous Insulin Therapy in people with Wound Healing and Diabetes, run by Florida Atlantic University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Administrative). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2016.