Skin Blood Flow Response to Insulin Iontophoresis in Pressure Ulcers of SCI
Status:
Withdrawn
Trial end date:
2018-04-01
Target enrollment:
Participant gender:
Summary
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.