Table 2.
Incomplete or Complete Clinical trials for PU/skin wound in the SCI and TBI.
| NCT # (Start–End) | Study Title (Phase) | # Enrolled/Completed (M/F) | Recruitment Status | Condition (SCI/TBI) | Treatment | Dose Frequency/repetition/duration | Country Co-Sponsor | Results | References |
|---|---|---|---|---|---|---|---|---|---|
| NCT01433159 (2011–2014) | Comparison of HP011-101 to standard care for stage I–II pressure ulcers in subjects with spinal cord injury (Phase 2) | 19 (M)/16 (M) | Terminated (business decision) | SCI | HP011-101 (Xenaderm Ointment) | Topical ointment applied daily (twice for 14 days) |
USA Healthpoint |
HP011-101 (Xenaderm Ointment) and Standard Care both showed an improved change in scores of the pressure ulcer scale for healing (PUSH) | NP |
| NCT02001558 (2013–2017) | Pressure ulcer healing with Microcyn (Phase 4) | 65 (55/10)/43 | Completed | SCI | Microcyn | Topical Microcyn sprayed on wound daily (twice for 24 weeks) |
USA University of Alabama |
Both microcyn and sterile saline (control) reduced ulcer size by more than half of baseline. The PUSH score improved slightly in both treatment groups. | NP |
| NCT01885962 (2012–2013) | Development and feasibility of an internet intervention for adults with spinal cord injury to prevent pressure ulcers (Phase—NA) | 19/NP | Completed | SCI | iSHIFTup: Internet skin health intervention for targeted ulcer prevention | NA |
USA University of Virginia |
NP | NP |
| NCT03317288 (2017–2019) | Alternating pressure overlay on weight-bearing tissue tolerance in people with spinal cord injury (Phase—NA) | 15/NP | Completed | SCI | Device: Dabir Air overlay | NP |
USA University of Illinois |
NP | NP |
| NCT02584426 (2017–2018) | Subcutaneous injection and ultrasonic dispersion of Cefazolin into chronic pelvic region pressure ulcers in persons with spinal cord injury (Phase—NA) | 20/NP | Unknown | SCI | Phonophoresis via ultrasonic distribution of Cefazolin | 1 Hypodermic antibiotic injection and Phonophoresis |
USA James J. Peters Veterans Affairs Medical Center |
NP | NP |
| NCT03220451 (2017–2020) | Use of adhesive elastic taping for the therapy of medium/severe pressure ulcers in spinal cord injured patients (Phase—NA) | 24/NP | Recruiting | SCI | Five-layer foam dressing on sacrum and installation of Heelmedix boot alternately from one foot to the other within 48 h after spinal surgery | NP |
Canada Centre Integre Universitaire de Sante et Services Sociaux du Nord de l’ile de Montreal |
NP | NP |
| NCT02894437 (2016–2018) | A qualitative study of the preventive organization of the pelvic bedsores injured spinal cord (QUALIPREPS) (NA) | 45/NP | Unknown | SCI | Conceptual framework for work established to prevent pelvic pressure ulcers |
NP |
France Nantes University Hospital |
NP | NP |
| NCT03469141 (2018–2021) | Interactive telehealth for pressure ulcer prevention after SCI (NA) | 100/NP | Recruiting | SCI | Biofeedback via smartphone app | Run biofeedback scan daily for 4 weeks |
USA Rancho Research Institute, Inc |
NP | NP |
| NCT01943201 (2010–2012) | Low friction bedsheet (NA) | 20/NP | Completed | SCI | Low-friction bed sheet | Daily for 5 nights |
Switzerland Swiss Paraplegic Centre Nottwil |
NP | NP |
| NCT03048357 (2016–2017) | Effectiveness of freedom bed compared to manual turning in the prevention of pressure injuries in persons with limited mobility due to traumatic brain injury and/or spinal cord injury (NA) | 8/NP | Unknown | TBI and/or SCI | Freedom bed | Daily for 6 months |
USA Northeast Center for Rehabilitation and Brain Injury |
NP | NP |
| NCT04402398 (2019–2020) | Psychometric properties of a mobile application (NA) | 59/NP | Completed | SCI | imitoMeasure (smartphone app that measures wound size) | NP |
France University Hospital, Montpellier |
NP | NP |
| NCT04266808 (2020–2022) | Interactive telehealth for wheelchair users (NA) | 50/NP | Not yet recruiting | SCI | Interactive telehealth monitoring and biofeedback system on phone application and wheelchair | Used for one year |
USA Rancho Research Institute, Inc. |
NP | NP |
| NCT02876666 (2017–2017) | Spinal cord injury virtual coach RCT (NA) | 40/NP | Completed | SCI | SCI virtual coach interaction | Once-daily for 2 months |
USA Boston University |
NP | NP |
| NCT01834417 (2013–2020) | Preliminary study leading to prevention of pressure ulcers by the use of an on-board device: Ergonomic assessment of wheelchair-seat pressures in spinal cord injured (SCI) patients (PRESDIE) (NA) | 90/NP | Completed | SCI | On-board device (on wheelchair): TexiMat | Use for 4 weeks |
France Nantes University Hospital |
NP | NP |
| NCT02412046 (2015–2018) | Quantification of the pressure threshold related to tissue injury in bed-ridden paraplegics (NA) | 21/NP | Terminated (Departure of the Ph.D. in charge of the study) | SCI | Muscle biopsy after lying on air mattress | One-time procedure |
France University Hospital, Montpellier |
NP | NP |
| NCT03114345 (2017–2020) | Correlation between pressure differences and micro-vascularization changes in bedridden paraplegic patient (NA) | 4/NP | Terminated (Departure of the Ph.D. in charge of the study) | SCI | XSensor | XSensor by bed for 1 h and O2C applied for 1 min; one-time procedure |
France University Hospital, Montpellier |
NP | NP |
| NCT04309864 (2020–2024) | CMAP refinement for pressure injury prevention (NA) | 46/NP | Recruiting | SCI | Comprehensive Mobile Assessment of Pressure (CMAP mobile app) | In-hospital: Use during initial rehabilitation In-home: Use for 2 weeks during daily routine |
USA VA Office of Research and Development |
NP | NP |
US-DVA—United States Department of Veterans Affairs; NP—not posted; NA—not applicable.