Skin Blood Flow Response to Insulin Iontophoresis in Pressure Ulcers of SCI
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|ClinicalTrials.gov Identifier: NCT02585765|
Recruitment Status : Recruiting
First Posted : October 23, 2015
Last Update Posted : March 3, 2017
Pressure ulcers (PU) are skin breakdowns that often form after blood flow in the skin is reduced from prolonged and repeated exposure to externally applied forces. As many as 85% of individuals with a spinal cord injury (SCI) report the occurrence of at least 1 PU since being injured. Despite the increasing attention and emphasis on prevention, PUs still represent a major health risk for persons with SCI. Among the numerous potential physical risk factors identified for the development of a PU were several conditions that have a significant negative effect on skin blood flow. In addition, improper management of blood sugar is a major risk factor for PU development and it impedes healing. It would appear that hormones (i.e., chemical signals in the blood) associated with how the body uses sugar that target the blood vessels may play an important role in the development and formation of a PU. In persons with SCI, skin blood flow responses to insulin (i.e., a hormone that helps the body use sugar and also relaxes the blood vessels allowing blood flow to increase) in the lower extremity were shown to be much lower than healthy individuals.
The proposed study in up to 30 individuals with chronic SCI and a difficult-to-heal pelvic region PU has 2 phases: (1) a 4-week "observation" phase [if the PU does not heal appropriately (determined by digital photos and software computation), and the subject is found to be insulin resistant then they will progress to the next phase of the study] and (2) an 8-week "treatment" phase. All participants will continue to receive the standard wound care throughout the observation and treatment phases. If the surface area of the PU does not decrease by more than 30% during the 4-week observation phase, the participant will be eligible to enter the 8-week treatment phase, in which they will be randomly assigned to receive active drug (e.g., pioglitazone) or placebo. The participants will have four study visits in which the following will be acquired: digital image of the wound to monitor wound surface area, skin blood flow measurements of the peri-wound area, and blood tests to monitor liver function, kidney function, blood sugar (hemoglobin A1C, insulin, glucose), nutritional status (albumin and pre-albumin), a complete blood count with differential, and makers of inflammation. Weekly monitoring of symptoms and participant experiences will be closely monitored.
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injury Pressure Ulcers||Drug: Pioglitazone Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Insulin Sensitivity in the Peri-Wound Microcirculation of Pressure Ulcers in SCI|
|Actual Study Start Date :||February 1, 2017|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Subjects will receive 8 weeks of daily pioglitazone (30mg/day).
8 weeks of daily pioglitazone (30 mg/d).
Placebo Comparator: Placebo
Subjects will receive 8 weeks of daily placebo capsules.
8 weeks of daily placebo capsules.
- Skin Perfusion Response to Insulin Administered by Iontophoresis to the Cutaneous Peri-Wound region of a Chronic Region Pressure Ulcer before and after treatment with Pioglitazone [ Time Frame: Before and After 8 Week Treatment with Pioglitazone ]To determine the perfusion response to insulin administered by iontophoresis to the cutaneous peri-wound region of a chronic pelvic region pressure ulcer before and after treatment with pioglitazone (30 mg/d x 8 weeks).
- Association between the therapeutic effects of pioglitazone on the homeostatic model assessment of insulin resistance (HOMA-IR) and cutaneous peri-wound perfusion response to transdermal insulin administration. [ Time Frame: Before and After 8 Week Treatment with Pioglitazone ]To determine the association between the therapeutic effects of pioglitazone on the homeostatic model assessment of insulin resistance (HOMA-IR) and cutaneous peri-wound perfusion response to transdermal insulin administration.
- Reliability of laser speckle contrast analysis imaging to detect meaningful interventional change in cutaneous peri-wound perfusion to pioglitazone treatment. [ Time Frame: Before and After 8 Week Treatment with Pioglitazone ]To determine the reliability of laser speckle contrast analysis imaging to detect meaningful interventional change in cutaneous peri-wound perfusion to pioglitazone treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02585765
|Contact: Joshua C Hobson, MS||(718) 584-9000 ext email@example.com|
|Contact: Michael LaFountaine, EdD||(718) 584-9000 ext firstname.lastname@example.org|
|United States, New York|
|James J. Peters VA Medical Center||Recruiting|
|Bronx, New York, United States, 10468|
|Contact: Mary Sano, PhD 718-584-9000 ext 6007 email@example.com|