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

NCT00967837 | Terminated Phase 2 DMC

• 1 other identifier: H09-66
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Wound Healing; Diabetes

Keywords

Diabetes with complications; Wound healing

Outcome Measures

Primary Outcomes (1)

• To measure progress of wound healing in subjects that have failed conventional wound care healing treatments for 60 days

  Monitoring of wound is done at baseline and weekly follow up visits including visual examination, pictures of wound and measurements

Study Arms (1)

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

Procedure: Pulsatile Intravenous Insulin Therapy

Interventions

Pulsatile Intravenous Insulin Therapy PROCEDURE

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.

Also known as: Humulin, Humulin R, Novolog

Diabetes with non healing wounds

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Florida Atlantic University: lead
• Advanced Diabetes Treatment Centers: collaborator

Study Sites (1)

Florida Atlantic University

Boca Raton, Florida, 33487, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Insulin, Regular, Human; Insulin; Insulin Aspart

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Short-Acting

Study Officials

• Betty Tuller, PhD

  Florida Atlantic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2009
• First Posted: August 28, 2009
• Study Start: January 1, 2006
• Primary Completion: January 1, 2012
• Study Completion: September 1, 2012
• Last Updated: August 10, 2016

Record last verified: 2016-08

Locations

US (1)