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NCT01541436 · ClinicalTrials.gov registry record · Early Phase 1
Remote Ischemic Preconditioning Mechanism Study
A Early Phase 1 study, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 20
- Enrollment target
NCT01541436: Completed Early Phase 1 study, sponsored by Wake Forest University Health Sciences.
NCT01541436 is a Early Phase 1 study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 20 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01541436, a Early Phase 1 study, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
This research is being done because pain is a significant problem for patients with a variety of medical problems and following surgery or traumatic injury. Currently available pain medications may not relieve all types of pain or may relieve pain only at doses that produce side effects and potential complications. Although Remote Ischemic Preconditioning (RIPC) appears promising, there remain several unanswered questions about how it works. This research trial will help determine how RIPC may activate the bodies natural pain control system. The goals of this study are to see if RIPC has any effect 1) on a small area of skin that will be expose to a small amount of UV- B radiation (a mild sunburn), 2) on acute thermal heat temperatures that will be applied to skin, and 3) on the sunburn-like sensation to light touch after putting capsaicin cream (the active ingredient in hot chili peppers) on skin. Remote ischemic preconditioning is done by inflating a balloon (very similar to a blood pressure cuff) on the leg until it blocks blood flow for a few minutes. The cuff is then deflated and blood flow resumes. The process is repeated up to three times. This procedure causes the body to increase its natural pain relief system that may help to decrease the amount of postsurgical pain.
Primary Outcome
Hyperalgesia will be measured with vonFrey fibers and allodynia will be measured with a cotton wisp. The area will be measured in cm2.
Interventions
- DEVICE Remote Ischemic Preconditioning, Capsaicin, UV-B
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2012-03 |
| Est. Completion | 2017-04-30 |
| Phase | Early Phase 1 |
What the finished NCT01541436 record still lists
NCT01541436 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 1 intervention - of which Remote Ischemic Preconditioning, Capsaicin, UV-B is the first listed.
NCT01541436 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01541436 about?
NCT01541436 is a clinical study titled "Remote Ischemic Preconditioning Mechanism Study". This research is being done because pain is a significant problem for patients with a variety of medical problems and following surgery or traumatic injury. Currently available pain medications may not relieve all types of pain or may relieve pain only at doses that produce side effects and potentia...
What is the current status of trial NCT01541436?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2012-03. Estimated completion is 2017-04-30.
What interventions are being tested in trial NCT01541436?
The interventions under investigation include: Remote Ischemic Preconditioning, Capsaicin, UV-B (DEVICE).
Who is sponsoring clinical trial NCT01541436?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01541436's enrollment target sits among peer trials
20 1157th of 2000 higher than 710 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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