Spinal Cord InjuryPhase 2NCT02585765
Skin Blood Flow Response to Insulin Iontophoresis in Pressure Ulcers of SCI
A Phase 2 study testing Pioglitazone in people with Spinal Cord Injury and Pressure Ulcers, run by James J. Peters Veterans Affairs Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Spinal Cord Injury, Pressure Ulcers
- What is being tested?
- Pioglitazone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 1 Apr 2018
- Phase
- Phase 2
- 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age 18 to 79;
- Chronic (e.g., duration of injury at least 6 months), stable SCI (regardless of level of neurological lesion);
- American Spinal Injury Association Impairment Scale (AIS) designation of A, B or C; and
- At least one Stage III or IV PU in the pelvic region (e.g., ischial, trochanteric, perineal, and sacral regions) that has not shown signs of healing for a period of at least 1 month.
- Hemoglobin A1C <7.0%
Who cannot join
- Persons who are candidates for or elect to have reconstructive flap surgery of the PU;
- Hemoglobin A1C ≥7.0%
- Psychopathology (documentation in the medical record or history of self-abusive behavior specific to PU healing which may or may not include major or minor psychiatric illness (that may conflict with the study objectives;
- Previously diagnosed active malignant disease;
- Suspicion of skin cancer at the PU site (i.e., clinical evaluation is currently on-going);
- Life expectancy less than 12 months;
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- Nephrosis, hemodialysis or chronic ambulatory peritoneal dialysis therapy;
- Acute illness or systemic infection (including MRSA);
- Current pharmacological treatment for diabetes mellitus or insulin resistance with exogenous insulin (or its synthetic dialogues), insulin-sensitizing agents, or agents that alter pancreatic secretion of insulin;
- Current pharmacological treatment with sympathomimetic agents demonstrating direct vascular actions or indirect implications (e.g., alpha-1 agonists, cholinesterase inhibitors, norepinephrine, calcium channel blockers, angiotensin converting enzymes);
- Moderate to high dose glucocorticoid administrations (i.e., ≥ 40 mg prednisone or equivalent steroid dose) within the past 3 months;
- Atherosclerosis, congestive heart failure, or recent history of myocardial infarction (<90 months);
- Previous diagnosis of diabetes mellitus or insulin resistance;
- Diminished mental capacity;
- Inability or unwillingness of subject to provide informed consent; or
- Pregnancy or women who may become pregnant during the course of the study, or those who are nursing.
Trial locations and contacts
1 site in 1 country.
United States1 site
James J. Peters VA Medical Center
The Bronx, New York, 10468
About this study
Official title: Insulin Sensitivity in the Peri-Wound Microcirculation of Pressure Ulcers in SCI
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.
Read the detailed description
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 strategies, PUs still represent a major risk for morbidity in persons with SCI. Among the numerous potential physical risk factors identified for the development of a PU were several conditions that have a significant adverse influences on skin blood flow. In addition, poor glycemic control is a major risk factor for PU development and it impedes healing. Thus, it would appear that vasoactive hormones associated with carbohydrate metabolism that target the endothelium may play an important role in the development and formation of a PU. In persons with SCI, skin blood flow responses to insulin in the lower extremity were shown to be much lower than healthy individuals despite no clinical signs of insulin resistance. In the skin next to a PU, the current proposal will determine if a once-daily treatment with pioglitazone for 8 weeks improves skin blood flow after insulin by iontophoresis.
- Conditions
- Spinal Cord Injury, Pressure Ulcers
- Being tested
- Pioglitazone, Placebo
- Medical subject headings
- Spinal Cord Injuries, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PioglitazoneDrug
8 weeks of daily pioglitazone (30 mg/d).
PlaceboDrug
8 weeks of daily placebo capsules.
| Study group | Role | What they receive |
|---|---|---|
| Pioglitazone | Experimental | Subjects will receive 8 weeks of daily pioglitazone (30mg/day). Receives: Drug: Pioglitazone |
| Placebo | Placebo comparator | Subjects will receive 8 weeks of daily placebo capsules. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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).
Measured: Before and After 8 Week Treatment with Pioglitazone
Secondary outcomes (1)
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.
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.
Measured: Before and After 8 Week Treatment with Pioglitazone
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2015 (estimated)
- Study start1 Feb 2017
- Primary completion1 Apr 2018
- Study completion1 Apr 2018
Why it stopped: an alternate plan of investigation was developed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- James J. Peters Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Michael LaFountaine, James J. Peters Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02585765
- Sponsor's protocol ID
- LAF-15-040
- Status last verified
- Aug 2018
- First submitted
- 22 Oct 2015
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Sensitivity in the Peri-Wound Microcirculation of Pressure Ulcers in SCI
- ClinicalTrials.gov ID
- NCT02585765
- Acronym / sponsor ID
- LAF-15-040
- Conditions
- Spinal Cord Injury, Pressure Ulcers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: an alternate plan of investigation was developed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- James J. Peters Veterans Affairs Medical CenterUS federal agency
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 1 Apr 2018 (actual)
- First posted
- 23 Oct 2015 (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.
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.
Detailed description
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 strategies, PUs still represent a major risk for morbidity in persons with SCI. Among the numerous potential physical risk factors identified for the development of a PU were several conditions that have a significant adverse influences on skin blood flow. In addition, poor glycemic control is a major risk factor for PU development and it impedes healing. Thus, it would appear that vasoactive hormones associated with carbohydrate metabolism that target the endothelium may play an important role in the development and formation of a PU. In persons with SCI, skin blood flow responses to insulin in the lower extremity were shown to be much lower than healthy individuals despite no clinical signs of insulin resistance. In the skin next to a PU, the current proposal will determine if a once-daily treatment with pioglitazone for 8 weeks improves skin blood flow after insulin by iontophoresis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pioglitazone | Experimental | Drug: PioglitazoneSubjects will receive 8 weeks of daily pioglitazone (30mg/day). |
| Placebo | Placebo comparator | Drug: PlaceboSubjects will receive 8 weeks of daily placebo capsules. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, age 18 to 79;
- Chronic (e.g., duration of injury at least 6 months), stable SCI (regardless of level of neurological lesion);
- American Spinal Injury Association Impairment Scale (AIS) designation of A, B or C; and
- At least one Stage III or IV PU in the pelvic region (e.g., ischial, trochanteric, perineal, and sacral regions) that has not shown signs of healing for a period of at least 1 month.
- Hemoglobin A1C <7.0%
Key exclusion criteria (16 listed)
- Persons who are candidates for or elect to have reconstructive flap surgery of the PU;
- Hemoglobin A1C ≥7.0%
- Psychopathology (documentation in the medical record or history of self-abusive behavior specific to PU healing which may or may not include major or minor psychiatric illness (that may conflict with the study objectives;
- Previously diagnosed active malignant disease;
- Suspicion of skin cancer at the PU site (i.e., clinical evaluation is currently on-going);
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 |
|---|---|---|
| Pioglitazone8 weeks of daily pioglitazone (30 mg/d). | Drug | Pioglitazone |
| Placebo8 weeks of daily placebo capsules. | Drug | Placebo |
Primary outcome
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).
1 secondary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pioglitazone in people with Spinal Cord Injury and Pressure Ulcers, run by James J. Peters Veterans Affairs Medical Center 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 16 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: withdrawn, as of the sponsor's last update on 8 Aug 2018. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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 withdrawn before enrolling participants, so there are no results.
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?
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). 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 8 Aug 2018.